<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03263442</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1726</org_study_id>
    <secondary_id>CCR-17-300</secondary_id>
    <nct_id>NCT03263442</nct_id>
  </id_info>
  <brief_title>High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rising Tide Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: To conduct a randomized controlled pilot study investigating the use of high dose&#xD;
      intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,&#xD;
      including health-related quality of life (HRQOL), functional status, and neuropsychiatric&#xD;
      outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic&#xD;
      hematopoietic stem cell transplant (HSCT).&#xD;
&#xD;
      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for&#xD;
      allogeneic stem cell transplant.&#xD;
&#xD;
      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after&#xD;
      transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will&#xD;
      be measured weekly and participants will be assessed for evidence of delirium using validated&#xD;
      measures. Validated measures will also be used to assess cognitive function, depression,&#xD;
      post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at&#xD;
      one, three, and six months after transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is a common and potentially preventable neuropsychiatric complication in cancer&#xD;
      patients receiving hematopoietic stem cell transplantation (HSCT) that has profound&#xD;
      consequences. Among cancer patients hospitalized for HSCT, delirium occurs in approximately&#xD;
      40% of patients and increases the risk of mortality. Long-term, delirium in this population&#xD;
      results in worse physical health, mental health, and quality of life. Though strategies to&#xD;
      prevent delirium have the potential to significantly improve the lives of people living with&#xD;
      cancer, research in this area is extremely limited. Thiamine deficiency is also ubiquitous&#xD;
      during HSCT and a known contributor to the development of delirium in other patient&#xD;
      populations. High dose intravenous (IV) thiamine is an evidence-based and promising treatment&#xD;
      for delirium, but no one has studied IV thiamine as a prevention strategy.&#xD;
&#xD;
      This is a randomized double-blind controlled trial in participants undergoing allogeneic HSCT&#xD;
      to determine if high dose IV thiamine can prevent delirium and minimize the deleterious&#xD;
      impact of delirium on health-related quality of life (HRQOL), functional status, and other&#xD;
      neuropsychiatric outcomes. The investigators will recruit 60 patients admitted for allogeneic&#xD;
      HSCT at UNC, randomize them to treatment with high dose IV thiamine (n = 30) versus placebo&#xD;
      (n = 30), and systematically evaluate all participants for delirium and related&#xD;
      comorbidities. The investigators will use the Delirium Rating Scale (DRS) to measure the&#xD;
      severity and duration of delirium immediately prior to transplant and after HSCT until 30&#xD;
      days post-transplant or discharge. If delirium is identified, the DRS will be administered&#xD;
      daily until delirium resolves. The investigators will obtain thiamine levels and other&#xD;
      laboratory parameters associated with delirium the day after transplant, and continue to&#xD;
      monitor thiamine levels weekly thereafter. The investigators will also monitor HRQOL,&#xD;
      functional status, depression, post-traumatic stress symptoms, and cognitive function prior&#xD;
      to transplant and at one, three, and six months after transplant to elucidate the persistent&#xD;
      impact of delirium in this population and the potential for thiamine to mitigate these&#xD;
      negative outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">March 2, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Delirium</measure>
    <time_frame>Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.</time_frame>
    <description>Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS &gt; 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delirium Severity</measure>
    <time_frame>Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5</time_frame>
    <description>Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delirium Duration</measure>
    <time_frame>Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.</time_frame>
    <description>Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS &gt; 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Thiamine Status Stratified by Delirium Status</measure>
    <time_frame>From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days</time_frame>
    <description>The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-related Quality of Life Scores (Month 1)</measure>
    <time_frame>From baseline to one month post-transplant</time_frame>
    <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-related Quality of Life Scores (Month 3)</measure>
    <time_frame>Baseline to three months post-transplant</time_frame>
    <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health-related Quality of Life Scores (Month 6)</measure>
    <time_frame>Baseline to six months post-transplant</time_frame>
    <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Scores (Month 1)</measure>
    <time_frame>Baseline to one month post-transplant</time_frame>
    <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Scores (Month 3)</measure>
    <time_frame>Baseline to three months post-transplant</time_frame>
    <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression Scores (Month 6)</measure>
    <time_frame>Baseline to six months post-transplant</time_frame>
    <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post-traumatic Stress Symptom Scores (Month 1)</measure>
    <time_frame>Baseline to one month post-transplant</time_frame>
    <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post-traumatic Stress Symptom Scores (Month 3)</measure>
    <time_frame>Baseline to three months post-transplant</time_frame>
    <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post-traumatic Stress Symptom Scores (Month 6)</measure>
    <time_frame>Baseline to six months post-transplant</time_frame>
    <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Function Scores (Month 1)</measure>
    <time_frame>From baseline to one month post-transplant</time_frame>
    <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Function Scores (Month 3)</measure>
    <time_frame>Baseline to three months post-transplant</time_frame>
    <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Function Scores (Month 6)</measure>
    <time_frame>From baseline to six months post-transplant</time_frame>
    <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Status Scores (Month 1)</measure>
    <time_frame>Baseline to one month post-transplant</time_frame>
    <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Status Scores (Month 3)</measure>
    <time_frame>From baseline to three months post-transplant</time_frame>
    <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Status Scores (Month 6)</measure>
    <time_frame>Baseline to six months post-transplant</time_frame>
    <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Delirium</condition>
  <condition>Thiamine Deficiency</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thiamine 200 mg IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thiamine</intervention_name>
    <description>200 mg IV three times daily for seven days</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Thiamine Hydrochloride Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline IV three times daily for seven days</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell&#xD;
             transplant&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of adverse reaction to IV thiamine&#xD;
&#xD;
          -  Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donald Rosenstein, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zev Nakamura, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>January 28, 2021</results_first_submitted>
  <results_first_submitted_qc>March 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2021</results_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Thiamine Deficiency</mesh_term>
    <mesh_term>Beriberi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thiamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03263442/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from the UNC Bone Marrow Transplant and Cellular Therapies Unit from October 2017 through February 2020.</recruitment_details>
      <pre_assignment_details>Of the 66 participants who enrolled in the study, 2 withdrew prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Inpatient Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inadequate Drug Exposure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1-month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3-month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-month Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only participants who met the following a priori criteria were counted: 1.) received all seven days of the treatment; 2.) received at least 17/21 (80%) scheduled study drug doses; and 3.) delirium was assessed at least weekly until the participant was found to be delirious, reached 30 days post-transplant, or was discharged.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.9" spread="12.5"/>
                    <measurement group_id="B2" value="53.6" spread="14.7"/>
                    <measurement group_id="B3" value="54.2" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <description>Years of education</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.7" spread="2.7"/>
                    <measurement group_id="B2" value="15.3" spread="2.7"/>
                    <measurement group_id="B3" value="15.0" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Acute leukemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chronic leukemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Myelodysplastic Syndrome</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Myeloproliferative Disorder</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CIBMTR Disease Risk Index</title>
          <description>CIBMTR: Center for International Blood and Marrow Transplant Research. Uses disease, stage, and cytogenetics to assigns low, intermediate, high, or very high risk related to overall survival after allogeneic hematopoietic stem cell transplant among patients with hematologic malignancies.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>N/A</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>low</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>intermediate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>high</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Donor Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Matched Related Donor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Matched Unrelated Donor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Haploidentical</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Conditioning Regimen</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Myeloablative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Reduced Intensity or Non-Myeloablative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Score</title>
          <description>A scale by the Eastern Cooperative Oncology Group (ECOG) from 0-5 to describe patient's selfcare ability and activity level.&#xD;
0, Fully active&#xD;
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature&#xD;
Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours&#xD;
Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours&#xD;
Completely disabled; cannot carry on any selfcare; totally confined to bed or chair&#xD;
Dead</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Delirium</title>
        <description>Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS &gt; 12.</description>
        <time_frame>Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.</time_frame>
        <population>The analysis population was defined a priori as those participants who: 1.) received at least 17 of 21 (80%) scheduled study drug doses; 2.) received at least one dose on each of the study drug administration days; and 3.) had no fewer than one DRS assessment per week until they were found to be delirious, reached 30 days post-transplant, or were discharged.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Delirium</title>
          <description>Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS &gt; 12.</description>
          <population>The analysis population was defined a priori as those participants who: 1.) received at least 17 of 21 (80%) scheduled study drug doses; 2.) received at least one dose on each of the study drug administration days; and 3.) had no fewer than one DRS assessment per week until they were found to be delirious, reached 30 days post-transplant, or were discharged.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delirium Severity</title>
        <description>Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups.</description>
        <time_frame>Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5</time_frame>
        <population>Attrition over time is due to hospital discharge (primary reason), withdrawal, or death.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium Severity</title>
          <description>Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups.</description>
          <population>Attrition over time is due to hospital discharge (primary reason), withdrawal, or death.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.0" upper_limit="8.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" lower_limit="3.0" upper_limit="9.0"/>
                    <measurement group_id="O2" value="4.67" lower_limit="2.67" upper_limit="15.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.50" lower_limit="2.67" upper_limit="20.33"/>
                    <measurement group_id="O2" value="5.33" lower_limit="2.33" upper_limit="16.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.33" lower_limit="1.00" upper_limit="18.60"/>
                    <measurement group_id="O2" value="5.17" lower_limit="2.00" upper_limit="17.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.50" lower_limit="4.00" upper_limit="20.00"/>
                    <measurement group_id="O2" value="6.00" lower_limit="5.00" upper_limit="13.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.00" lower_limit="20.00" upper_limit="20.00"/>
                    <measurement group_id="O2" value="7.50" lower_limit="4.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delirium Duration</title>
        <description>Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS &gt; 12.</description>
        <time_frame>Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.</time_frame>
        <population>These analyses are exclusive to those participants who experienced delirium.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium Duration</title>
          <description>Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of &gt; 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS &gt; 12.</description>
          <population>These analyses are exclusive to those participants who experienced delirium.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.2"/>
                    <measurement group_id="O2" value="4.4" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Thiamine Status Stratified by Delirium Status</title>
        <description>The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium.</description>
        <time_frame>From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days</time_frame>
        <population>Only those participants in whom thiamine levels were obtained at the end of the seven day administration were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Delirium</title>
            <description>Participants who experienced delirium, defined as at least one DRS score &gt;12, during the post-transplant hospitalization.</description>
          </group>
          <group group_id="O2">
            <title>No Delirium</title>
            <description>Participants who did not meet criteria for delirium during the post-transplant hospitalization.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Thiamine Status Stratified by Delirium Status</title>
          <description>The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium.</description>
          <population>Only those participants in whom thiamine levels were obtained at the end of the seven day administration were included.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.6" spread="69.3"/>
                    <measurement group_id="O2" value="93.8" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Health-related Quality of Life Scores (Month 1)</title>
        <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
        <time_frame>From baseline to one month post-transplant</time_frame>
        <population>Participants who completed the 1 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Health-related Quality of Life Scores (Month 1)</title>
          <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
          <population>Participants who completed the 1 month follow-up period.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.53" spread="11.66"/>
                    <measurement group_id="O2" value="-5.69" spread="11.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Health-related Quality of Life Scores (Month 3)</title>
        <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
        <time_frame>Baseline to three months post-transplant</time_frame>
        <population>Participants who completed the 3 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Health-related Quality of Life Scores (Month 3)</title>
          <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
          <population>Participants who completed the 3 month follow-up period</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.96" spread="9.11"/>
                    <measurement group_id="O2" value="-1.43" spread="16.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Health-related Quality of Life Scores (Month 6)</title>
        <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
        <time_frame>Baseline to six months post-transplant</time_frame>
        <population>Participants who completed the 6 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Health-related Quality of Life Scores (Month 6)</title>
          <description>HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.</description>
          <population>Participants who completed the 6 month follow-up period</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.36" spread="14.09"/>
                    <measurement group_id="O2" value="0.28" spread="12.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression Scores (Month 1)</title>
        <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
        <time_frame>Baseline to one month post-transplant</time_frame>
        <population>Participants who completed the 1 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Scores (Month 1)</title>
          <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
          <population>Participants who completed the 1 month follow-up period.</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="8.28"/>
                    <measurement group_id="O2" value="1.16" spread="6.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression Scores (Month 3)</title>
        <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
        <time_frame>Baseline to three months post-transplant</time_frame>
        <population>Participants who completed the 3 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Scores (Month 3)</title>
          <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
          <population>Participants who completed the 3 month follow-up period</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="6.24"/>
                    <measurement group_id="O2" value="0.32" spread="9.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Depression Scores (Month 6)</title>
        <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
        <time_frame>Baseline to six months post-transplant</time_frame>
        <population>Participants who completed the 6 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Depression Scores (Month 6)</title>
          <description>Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.</description>
          <population>Participants who completed the 6 month follow-up period</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.14" spread="6.88"/>
                    <measurement group_id="O2" value="-1.66" spread="7.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Post-traumatic Stress Symptom Scores (Month 1)</title>
        <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
        <time_frame>Baseline to one month post-transplant</time_frame>
        <population>Participants who completed the 1 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Post-traumatic Stress Symptom Scores (Month 1)</title>
          <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
          <population>Participants who completed the 1 month follow-up period.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="10.88"/>
                    <measurement group_id="O2" value="1.55" spread="6.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Post-traumatic Stress Symptom Scores (Month 3)</title>
        <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
        <time_frame>Baseline to three months post-transplant</time_frame>
        <population>Participants who completed the 3 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Post-traumatic Stress Symptom Scores (Month 3)</title>
          <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
          <population>Participants who completed the 3 month follow-up period</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.50" spread="6.58"/>
                    <measurement group_id="O2" value="0.83" spread="5.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Post-traumatic Stress Symptom Scores (Month 6)</title>
        <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
        <time_frame>Baseline to six months post-transplant</time_frame>
        <population>Participants who completed the 6 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Post-traumatic Stress Symptom Scores (Month 6)</title>
          <description>Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.</description>
          <population>Participants who completed the 6 month follow-up period.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="9.14"/>
                    <measurement group_id="O2" value="1.32" spread="7.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Function Scores (Month 1)</title>
        <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
        <time_frame>From baseline to one month post-transplant</time_frame>
        <population>One participant in the control arm was unable to complete the MoCA due to restrictions on in-person human subjects research during the COVID-19 pandemic. Otherwise, all participants available at the 1-month follow-up time point were included.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Function Scores (Month 1)</title>
          <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
          <population>One participant in the control arm was unable to complete the MoCA due to restrictions on in-person human subjects research during the COVID-19 pandemic. Otherwise, all participants available at the 1-month follow-up time point were included.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="3.35"/>
                    <measurement group_id="O2" value="-0.09" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Function Scores (Month 3)</title>
        <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
        <time_frame>Baseline to three months post-transplant</time_frame>
        <population>Participants who completed the 3 month follow-up period and we able to participate in the cognitive assessment. Of the 26 participants active in the thiamine arm at the 3 month follow-up, 1 did not complete this measure due to barriers related to the COVID-19 pandemic.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Function Scores (Month 3)</title>
          <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
          <population>Participants who completed the 3 month follow-up period and we able to participate in the cognitive assessment. Of the 26 participants active in the thiamine arm at the 3 month follow-up, 1 did not complete this measure due to barriers related to the COVID-19 pandemic.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.97"/>
                    <measurement group_id="O2" value="0.97" spread="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cognitive Function Scores (Month 6)</title>
        <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
        <time_frame>From baseline to six months post-transplant</time_frame>
        <population>Participants who completed the 6 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Cognitive Function Scores (Month 6)</title>
          <description>Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.</description>
          <population>Participants who completed the 6 month follow-up period.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="3.32"/>
                    <measurement group_id="O2" value="1.54" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Functional Status Scores (Month 1)</title>
        <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
        <time_frame>Baseline to one month post-transplant</time_frame>
        <population>Participants who completed the 1 month follow-up period</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Status Scores (Month 1)</title>
          <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
          <population>Participants who completed the 1 month follow-up period</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.67"/>
                    <measurement group_id="O2" value="0.88" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Functional Status Scores (Month 3)</title>
        <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
        <time_frame>From baseline to three months post-transplant</time_frame>
        <population>Participants who completed the 3 month follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Status Scores (Month 3)</title>
          <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
          <population>Participants who completed the 3 month follow-up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.62"/>
                    <measurement group_id="O2" value="0.60" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Functional Status Scores (Month 6)</title>
        <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
        <time_frame>Baseline to six months post-transplant</time_frame>
        <population>Participants who completed the 6 month follow-up period.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Functional Status Scores (Month 6)</title>
          <description>Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.</description>
          <population>Participants who completed the 6 month follow-up period.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.93"/>
                    <measurement group_id="O2" value="0.21" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event (AE) data were only collected from October 2017 through February 2020, during the intervention phase of the study and coinciding with participants' hospitalization for hematopoietic stem cell transplantation. This phase lasted up to 30 days for each participant. The study was completed on August 10, 2020, as secondary outcomes were collected for an additional 5 months after completion of AE data collection.</time_frame>
      <desc>Adverse events were were graded per NCI CTCAE v. 4 criteria.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Thiamine 200 mg IV&#xD;
Thiamine: 200 mg IV three times daily for seven days</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Normal saline IV&#xD;
Normal saline: Normal saline IV three times daily for seven days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Zev Nakamura</name_or_title>
      <organization>University of North Carolina - Chapel Hill</organization>
      <phone>984-974-3829</phone>
      <email>zev_nakamura@med.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03263442
org study id: LCCC1726
secondary id: CCR-17-300
nct id: NCT03263442
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Purpose: To conduct a randomized controlled pilot study investigating the use of high dose
      intravenous (IV) thiamine to prevent delirium and mitigate the long-term effects of delirium,
      including health-related quality of life (HRQOL), functional status, and neuropsychiatric
      outcomes, in patients admitted to University of North Carolina (UNC) Hospital for allogeneic
      hematopoietic stem cell transplant (HSCT).

      Participants: 60 adult inpatients admitted to the UNC Bone Marrow Transplant Unit for
      allogeneic stem cell transplant.

      Procedures (methods): Participants will be admitted for allogeneic HSCT and on the day after
      transplant randomized to seven days of high dose IV thiamine or placebo. Thiamine levels will
      be measured weekly and participants will be assessed for evidence of delirium using validated
      measures. Validated measures will also be used to assess cognitive function, depression,
      post-traumatic stress symptoms, functional status, and HRQOL prior to hospitalization and at
      one, three, and six months after transplant.
Delirium is a common and potentially preventable neuropsychiatric complication in cancer
      patients receiving hematopoietic stem cell transplantation (HSCT) that has profound
      consequences. Among cancer patients hospitalized for HSCT, delirium occurs in approximately
      40% of patients and increases the risk of mortality. Long-term, delirium in this population
      results in worse physical health, mental health, and quality of life. Though strategies to
      prevent delirium have the potential to significantly improve the lives of people living with
      cancer, research in this area is extremely limited. Thiamine deficiency is also ubiquitous
      during HSCT and a known contributor to the development of delirium in other patient
      populations. High dose intravenous (IV) thiamine is an evidence-based and promising treatment
      for delirium, but no one has studied IV thiamine as a prevention strategy.

      This is a randomized double-blind controlled trial in participants undergoing allogeneic HSCT
      to determine if high dose IV thiamine can prevent delirium and minimize the deleterious
      impact of delirium on health-related quality of life (HRQOL), functional status, and other
      neuropsychiatric outcomes. The investigators will recruit 60 patients admitted for allogeneic
      HSCT at UNC, randomize them to treatment with high dose IV thiamine (n = 30) versus placebo
      (n = 30), and systematically evaluate all participants for delirium and related
      comorbidities. The investigators will use the Delirium Rating Scale (DRS) to measure the
      severity and duration of delirium immediately prior to transplant and after HSCT until 30
      days post-transplant or discharge. If delirium is identified, the DRS will be administered
      daily until delirium resolves. The investigators will obtain thiamine levels and other
      laboratory parameters associated with delirium the day after transplant, and continue to
      monitor thiamine levels weekly thereafter. The investigators will also monitor HRQOL,
      functional status, depression, post-traumatic stress symptoms, and cognitive function prior
      to transplant and at one, three, and six months after transplant to elucidate the persistent
      impact of delirium in this population and the potential for thiamine to mitigate these
      negative outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants With Delirium
time frame: Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.
description: Delirium incidence will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium incidence will be defined as at least one assessment with DRS > 12.
measure: Delirium Severity
time frame: Assessments will occur in the week prior to transplant (baseline), then at least 3 times post-transplant on a weekly basis until 30 days post-transplant or discharge, whichever comes first, up to week 5
description: Delirium severity will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The score ranges from 0 to 32 with higher scores reflecting more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. The DRS medians and ranges are reported for each group at baseline and in each week of hospitalization for thiamine and placebo groups.
measure: Delirium Duration
time frame: Assessments will occur in the week prior to transplant, then 3 times weekly post-transplant until 30 days post-transplant or discharge, whichever comes first.
description: Delirium duration will be measured using the Delirium Rating Scale (DRS). The DRS is a is a 10-item, clinician-rated scale that rates the severity of delirium symptoms over a 24-hour period using all available information from the patient interview, mental status examination, medical history and tests, nursing observations, and family reports. The maximum possible score is 32. Higher scores suggest more severe symptoms. A cut-off score of > 12 has been suggested to distinguish patients with delirium from patients with other neuropsychiatric disorders. Delirium duration will be reported as number of consecutive days during which DRS > 12.
measure: Concentration of Thiamine Status Stratified by Delirium Status
time frame: From end of 7-day intervention period until the development of delirium at any point during the post-transplant hospitalization up to a maximum of 30 days
description: The relationship between thiamine levels at the end of the seven day administration of thiamine and the development of delirium at any point during the thirty days post-transplant or the post-transplant hospitalization, whichever comes first, will be examined. Thiamine levels (nmol/L) are presented in participants who did and did not experience delirium.
measure: Change in Health-related Quality of Life Scores (Month 1)
time frame: From baseline to one month post-transplant
description: HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
measure: Change in Health-related Quality of Life Scores (Month 3)
time frame: Baseline to three months post-transplant
description: HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
measure: Change in Health-related Quality of Life Scores (Month 6)
time frame: Baseline to six months post-transplant
description: HRQOL will be assessed using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). The FACT-BMT is a 47-item self-administered assessment which asks individuals to rate questions related to physical, social/family, emotional, and functional well-being on a 5-point Likert Scale (0, not at all to 4, very much). Scores are summed across the items, resulting in a score from 0 to 148, with higher scores indicating better quality of life. Negative change scores indicate worse HRQOL with time.
measure: Change in Depression Scores (Month 1)
time frame: Baseline to one month post-transplant
description: Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
measure: Change in Depression Scores (Month 3)
time frame: Baseline to three months post-transplant
description: Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
measure: Change in Depression Scores (Month 6)
time frame: Baseline to six months post-transplant
description: Depression will be assessed using the Patient Reported Outcomes Measurement Information System - Depression (PROMIS-D) 8a short form. Scores for all PROMIS measures are reported on the T-score metric in which the mean=50 and standard deviation (SD) = 10 are centered on the general population means. Higher scores represent greater degrees of mood symptoms. Positive change scores indicate worse mood over time.
measure: Change in Post-traumatic Stress Symptom Scores (Month 1)
time frame: Baseline to one month post-transplant
description: Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.
measure: Change in Post-traumatic Stress Symptom Scores (Month 3)
time frame: Baseline to three months post-transplant
description: Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.
measure: Change in Post-traumatic Stress Symptom Scores (Month 6)
time frame: Baseline to six months post-transplant
description: Post-traumatic stress symptoms will be measured using the Post Traumatic Stress Syndrome Scale 14 (PTSS-14). The PTSS-14 is a 14-item self-administered assessment. Questions are on a 7-point Likert-type Scale (1, never to 7, always) resulting in a total score between 14 and 98. Higher scores represent a more likely diagnosis of post-traumatic stress disorder (PTSD). Positive change scores indicate worse post-traumatic stress over time.
measure: Change in Cognitive Function Scores (Month 1)
time frame: From baseline to one month post-transplant
description: Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.
measure: Change in Cognitive Function Scores (Month 3)
time frame: Baseline to three months post-transplant
description: Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.
measure: Change in Cognitive Function Scores (Month 6)
time frame: From baseline to six months post-transplant
description: Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). The MOCA is a clinician-administered tool with scores ranging from 0 to 30. Lower scores indicate worse cognitive function. Scores ≤ 25 are considered clinically significant. Positive change scores indicate better function with time.
measure: Change in Functional Status Scores (Month 1)
time frame: Baseline to one month post-transplant
description: Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.
measure: Change in Functional Status Scores (Month 3)
time frame: From baseline to three months post-transplant
description: Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.
measure: Change in Functional Status Scores (Month 6)
time frame: Baseline to six months post-transplant
description: Functional status will be measured using the Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG performance status is a single question scored on a 6-point scale (range 0 to 5) with higher scores representing greater physical restriction due to illness. Negative change scores indicate better function with time.
arm group label: Intervention
arm group type: Experimental
description: Thiamine 200 mg IV
arm group label: Control
arm group type: Placebo Comparator
description: Normal saline IV
intervention type: Drug
intervention name: Thiamine
description: 200 mg IV three times daily for seven days
arm group label: Intervention
other name: Thiamine Hydrochloride Injection
intervention type: Drug
intervention name: Normal saline
description: Normal saline IV three times daily for seven days
arm group label: Control
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Donald Rosenstein, MD
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
last name: Zev Nakamura, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Delirium
mesh term: Thiamine Deficiency
mesh term: Beriberi
mesh term: Thiamine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 