<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/NCT03806556</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18100519</org_study_id>
    <nct_id>NCT03806556</nct_id>
  </id_info>
  <brief_title>A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia</brief_title>
  <official_title>A Pediatric Trial Using Tranexamic Acid in Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meghan McCormick</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the use of tranexamic acid (TXA) in addition to standard therapy in&#xD;
      children receiving chemotherapy or blood and/or marrow transplantation to decrease the risk&#xD;
      of bleeding. Half of participants will receive tranexamic acid and half of participants will&#xD;
      receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to conduct a prospective, randomized, blinded, placebo&#xD;
      controlled trial to evaluate the safety and feasibility of the addition of antifibrinolytic&#xD;
      therapy with tranexamic acid to the standard care in patients who are thrombocytopenic due to&#xD;
      primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy in&#xD;
      order to prevent bleeding. The results of this study will change practice by providing&#xD;
      evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to&#xD;
      platelet transfusion therapy in the thrombocytopenic patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low accrual rate, strategic reasons&#xD;
  </why_stopped>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Actual">August 25, 2020</completion_date>
  <primary_completion_date type="Actual">August 25, 2020</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>This trial is designed as a prospective, randomized, controlled, blinded (patient, caregiver, physician, assessor) trial with two parallel groups and a primary endpoint of feasibility and safety. Randomization will be performed as block randomization with a 1:1 allocation within blocks of size four.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The investigational pharmacy will be notified when patients enroll on trial. When participants meet criteria for randomization, this will be completed by the Investigational Pharmacy. The pharmacy will prepare and distribute to floor nursing staff all doses of tranexamic acid (available in IV form as a colorless liquid) or placebo (as an equal volume of normal saline). Labels will not carry identifiers of which study arm the enrolled patient is on.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03</measure>
    <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
    <description>Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited</measure>
    <time_frame>From time of recruitment of the first patient until the last patient is enrolled, up to 16 months in duration</time_frame>
    <description>Number of participants eligible for study enrollment and recruited.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding</measure>
    <time_frame>30 days after activation of study drug</time_frame>
    <description>Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Platelet and Red Blood Cell Transfusions</measure>
    <time_frame>30 days after activation of study drug</time_frame>
    <description>Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Alive and Without WHO Grade 2 Bleeding or Greater</measure>
    <time_frame>30 days after activation of study drug</time_frame>
    <description>Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Occurrence of Thromboembolic Adverse Events and Serious Adverse Events</measure>
    <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
    <description>Any venous or arterial thrombosis on standard diagnostic imaging post-randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding of Any Grade</measure>
    <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
    <description>Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period</measure>
    <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
    <description>Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Pediatric Cancer</condition>
  <condition>Thrombocytopenia</condition>
  <condition>Hemostatic Disorder</condition>
  <condition>Coagulation Defect; Acquired</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>IV medication administered after patient meets inclusion/exclusion criteria</description>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <other_name>TXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>IV medication administered after patient meets inclusion/exclusion criteria</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>NS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a confirmed diagnosis of hematologic malignancy or solid tumor&#xD;
             malignancy&#xD;
&#xD;
          -  Patients must be undergoing or planned chemotherapy or BMT&#xD;
&#xD;
          -  Patients will only be eligible to receive study drug or placebo during inpatient&#xD;
             periods&#xD;
&#xD;
          -  Patients must be predicted to have thrombocytopenia ≤20,000/microliter (uL) for ≥5&#xD;
             days&#xD;
&#xD;
          -  Patient must have a platelet transfusion threshold of ≤30,000/uL&#xD;
&#xD;
          -  Patients must be &gt;14 days beyond their last dose of Pegylated(PEG)-Asparaginase or &gt;72&#xD;
             hours beyond their last dose of Erwinia Asparaginase&#xD;
&#xD;
          -  Patients must be able to comply with treatment and monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acute promyelocytic leukemia (APL)&#xD;
&#xD;
          -  History of Immune Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenic Purpura&#xD;
             (TTP) or Hemolytic Uremic Syndrome (HUS)&#xD;
&#xD;
          -  Diagnosis of Disseminated Intravascular Coagulopathy (DIC)&#xD;
&#xD;
          -  History of inherited or acquired bleeding disorder AND/OR inherited or acquired&#xD;
             prothrombotic disorder&#xD;
&#xD;
          -  Patient must not have WHO Grade 2 bleeding or greater within 48 hours prior to&#xD;
             enrollment or study drug activation&#xD;
&#xD;
          -  Patient must not have received PEG-Asparaginase within the 7 day period prior to&#xD;
             enrollment. If given within the 8-14 day period prior to enrollment patients are&#xD;
             eligible if prothrombin time (PT), partial thromboplastin time (PTT), international&#xD;
             normalized ratio (INR) and fibrinogen are obtained and are within 1.5 times the upper&#xD;
             limits of normal.&#xD;
&#xD;
          -  Patient must not be receiving tranexamic acid or other anti-fibrinolytic agent or any&#xD;
             other agent to promote hemostasis (which includes DDAVP, recombinant Factor VII,&#xD;
             Prothrombin Complex Concentrate, Estrogen Derivatives and Progestins)&#xD;
&#xD;
          -  Patient must not be receiving therapy with anticoagulation or antiplatelet therapy&#xD;
             (which includes heparin infusion, enoxaparin, aspirin. If anticoagulant/antiplatelet&#xD;
             therapy is discontinued when platelet count is &lt;50,000/uL patient will be eligible for&#xD;
             enrollment)&#xD;
&#xD;
          -  Patient must not be receiving platelet growth factors&#xD;
&#xD;
          -  Current thromboembolic event&#xD;
&#xD;
          -  History of thromboembolic event &lt;6 months prior to enrollment&#xD;
&#xD;
          -  Current/prior history of sinusoidal obstruction disease&#xD;
&#xD;
          -  Visible hematuria&#xD;
&#xD;
          -  Renal dysfunction (as defined by age-specific creatinine values calculated by Schwartz&#xD;
             equation) or hemodialysis or anuria (defined as &lt;10 mL urine/hour over 24 hours)&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Allergy to tranexamic acid&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unwilling to accept blood product transfusions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meghan McCormick, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPMC Childrens Hospital of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Childrens Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>July 27, 2021</results_first_submitted>
  <results_first_submitted_qc>August 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2021</results_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Meghan McCormick</investigator_full_name>
    <investigator_title>Principal Investigator, Fellow</investigator_title>
  </responsible_party>
  <keyword>tranexamic acid</keyword>
  <keyword>anti-fibrinolytic agents</keyword>
  <keyword>chemotherapy-induced thrombocytopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized public data set will be available after publication of primary results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Beginning within 1 year and ending 5 years after trial completion</ipd_time_frame>
    <ipd_access_criteria>Researchers who provide a methodologically sound proposal may request data. Proposals should be directed to meghan.mccormick3@chp.edu. To gain access data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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>January 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03806556/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03806556/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Tranexamic Acid</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Tranexamic Acid</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</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="6"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" lower_limit="3" upper_limit="18"/>
                    <measurement group_id="B2" value="11" lower_limit="3" upper_limit="12"/>
                    <measurement group_id="B3" value="11" lower_limit="3" upper_limit="18"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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>Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Lymphoid Leukemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Myeloid Leukemia</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>Lymphoma</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>Solid Tumor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Chemotherapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Autologous Hematopoietic Stem Cell Transplant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Allogeneic Hematopoietic Stem Cell Transplant</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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03</title>
        <description>Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.</description>
        <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03</title>
          <description>Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 3 Adverse Events : Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Anorexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Bone Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Catheter Related Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Febrile Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Hypoalbuminemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Hypoxia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Hypophosphatemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Rash Maculo-Papular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Mucositis Oral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Sinusitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Skin Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : White Blood Cell Decreases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Platelet Count Decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Adverse Events : Blood Bilirubin Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Anorexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Bone Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Catheter Related Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Febrile Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Hypoalbuminemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Hypoxia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Hypophosphatemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Rash Maculo-Papular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Mucositis Oral</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Sinusitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Skin Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : White Blood Cell Decreases</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Platelet Count Decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Adverse Events : Blood Bilirubin Increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited</title>
        <description>Number of participants eligible for study enrollment and recruited.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.</description>
        <time_frame>From time of recruitment of the first patient until the last patient is enrolled, up to 16 months in duration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Overall Study</title>
            <description>All patients assessed for eligibility as defined by diagnosis of hematologic or solid tumor malignancy and anticipated platelet counts ≤20,000/uL for ≥5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited</title>
          <description>Number of participants eligible for study enrollment and recruited.&#xD;
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Assessed for Eligibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Screened for Complete Inclusion/Exclusion Criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eligible for Enrollment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Consented to Participate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding</title>
        <description>Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
        <time_frame>30 days after activation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding</title>
          <description>Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Platelet and Red Blood Cell Transfusions</title>
        <description>Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug</description>
        <time_frame>30 days after activation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Platelet and Red Blood Cell Transfusions</title>
          <description>Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug</description>
          <units>transfusions</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of platelet transfusions per patient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="4" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of pRBC transfusions per patient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Alive and Without WHO Grade 2 Bleeding or Greater</title>
        <description>Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
        <time_frame>30 days after activation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Alive and Without WHO Grade 2 Bleeding or Greater</title>
          <description>Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="2" upper_limit="8"/>
                    <measurement group_id="O2" value="10.4" lower_limit="1" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Occurrence of Thromboembolic Adverse Events and Serious Adverse Events</title>
        <description>Any venous or arterial thrombosis on standard diagnostic imaging post-randomization</description>
        <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>The Occurrence of Thromboembolic Adverse Events and Serious Adverse Events</title>
          <description>Any venous or arterial thrombosis on standard diagnostic imaging post-randomization</description>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bleeding of Any Grade</title>
        <description>Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug</description>
        <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding of Any Grade</title>
          <description>Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period</title>
        <description>Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
        <time_frame>From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Tranexamic Acid</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
          </group>
        </group_list>
        <measure>
          <title>Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period</title>
          <description>Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5 Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of activation of the study drug up to and including 30 days after the last dose of the study drug, an average of 41 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Tranexamic Acid</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).&#xD;
Tranexamic Acid: IV medication administered after patient meets inclusion/exclusion criteria</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.&#xD;
Normal saline: IV medication administered after patient meets inclusion/exclusion criteria</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE v.4.03</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>White Blood Cell Decreased</sub_title>
                <description>Grade 4</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <description>Grade 4</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <description>Grade 4</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <description>Grade 4</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE v.4.03</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <description>Anemia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <description>Febrile Neutropenia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <description>Vomiting (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Nausea (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Mucositis Oral</sub_title>
                <description>Mucositis Oral (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <description>Fever (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Catheter Related Infection</sub_title>
                <description>Catheter Related Infection (Grade 3)</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <description>Sinusitis (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <description>Anorexia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <description>Hypoalbuminemia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <description>Hypophosphatemia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone Pain</sub_title>
                <description>Bone Pain (Grade 3)</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <description>Hypoxia (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash Maculo-papular</sub_title>
                <description>Rash Maculo-papular (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Hypotension (Grade 3)</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The pre-specified analysis described in the study protocol stated the following: &quot;For secondary endpoints, events of WHO Grade 2 or higher bleeding will be compared through the use of odds ratio or T-test statistic of means. The mean number of platelet transfusions will be analyzed using a T-test statistic of means.&quot; This analysis was not completed as it would be scientifically inappropriate due to insufficient enrollment. Instead a descriptive analysis was completed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Meghan McCormick, MD MS</name_or_title>
      <organization>University of Pittsburgh Medical Center</organization>
      <phone>412-692-6938</phone>
      <email>meghan.mccormick3@chp.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/NCT03806556
org study id: PRO18100519
nct id: NCT03806556
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the use of tranexamic acid (TXA) in addition to standard therapy in
      children receiving chemotherapy or blood and/or marrow transplantation to decrease the risk
      of bleeding. Half of participants will receive tranexamic acid and half of participants will
      receive placebo.
The purpose of this study is to conduct a prospective, randomized, blinded, placebo
      controlled trial to evaluate the safety and feasibility of the addition of antifibrinolytic
      therapy with tranexamic acid to the standard care in patients who are thrombocytopenic due to
      primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy in
      order to prevent bleeding. The results of this study will change practice by providing
      evidence as to whether or not TXA is effective and safe treatment when used as an adjunct to
      platelet transfusion therapy in the thrombocytopenic patient.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This trial is designed as a prospective, randomized, controlled, blinded (patient, caregiver, physician, assessor) trial with two parallel groups and a primary endpoint of feasibility and safety. Randomization will be performed as block randomization with a 1:1 allocation within blocks of size four.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The investigational pharmacy will be notified when patients enroll on trial. When participants meet criteria for randomization, this will be completed by the Investigational Pharmacy. The pharmacy will prepare and distribute to floor nursing staff all doses of tranexamic acid (available in IV form as a colorless liquid) or placebo (as an equal volume of normal saline). Labels will not carry identifiers of which study arm the enrolled patient is on.
measure: Safety and Tolerability of Tranexamic Acid in Participants as the Number of Patients With Any Adverse Events and Serious Adverse Events (SAE) as Assessed by CTCAE v4.03
time frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
description: Adverse Events and Serious Adverse Events (SAE) will be collected on subjects throughout their participation in the study and up to 30 days following discontinuation of the study drug, regardless of attribution. Adverse events and serious adverse events will be tabulated by type and grade according to the NCI CTCAE v 4.03.
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. Analysis limited to a descriptive assessment of the safety of tranexamic acid in patients with hematologic malignancies or solid tumors by reported adverse events, serious adverse events and death.
measure: Feasibility of Tranexamic Acid as an Adjunct to Standard Therapy: Number of Participants Eligible and Recruited
time frame: From time of recruitment of the first patient until the last patient is enrolled, up to 16 months in duration
description: Number of participants eligible for study enrollment and recruited.
The hypothesis is that tranexamic acid can be safely added to standard care regimens in patients with hematologic malignancies or solid tumors during periods of severe thrombocytopenia. A descriptive assessment of feasibility of recruitment by monitoring number of patients screened, number of patients eligible for enrollment and rate of recruitment (both start-up and ongoing) during study period to be completed by collecting data on the number of patients screened, the number of patients eligible for study inclusion, the number of eligible patients who consent to study inclusion and the number of consented patients activated to the study drug, organized in visual form by CONSORT diagram.
measure: World Health Organization (WHO) Bleeding Scale Grade 2 or Higher Bleeding
time frame: 30 days after activation of study drug
description: Proportion of patients with bleeding of WHO grade 2 or above, after activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
measure: Number of Platelet and Red Blood Cell Transfusions
time frame: 30 days after activation of study drug
description: Number of platelet and red blood cell transfusions per patient during the first 30 days post prescription activation of study drug
measure: Number of Days Alive and Without WHO Grade 2 Bleeding or Greater
time frame: 30 days after activation of study drug
description: Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
measure: The Occurrence of Thromboembolic Adverse Events and Serious Adverse Events
time frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
description: Any venous or arterial thrombosis on standard diagnostic imaging post-randomization
measure: Bleeding of Any Grade
time frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
description: Proportion of patients with bleeding of any grade as assessed by WHO bleeding score, after activation of study drug
measure: Highest Observed Grade of Bleeding (as Measured on WHO Bleeding Scale) During the Study Period
time frame: From activation of the study drug (maximum 30 days) through 30 days from discontinuation of study drug
description: Highest grade of bleeding (as measured on WHO bleeding scale) during study period in each enrolled patient. Bleeding graded on a scale ranging from 1 (minor bleeding) through 4 (bleeding that is fatal or life-threatening).
arm group label: Tranexamic Acid
arm group type: Experimental
description: Doses will be given intravenous (IV). Doses are administered every 8 hours or three times daily (TID) per the discretion of the treating investigator. TXA dose will be 10mg/kg, diluted in normal saline to a total volume of 15 milliliters (mL).
arm group label: Placebo
arm group type: Placebo Comparator
description: Doses will be given intravenous (IV). Doses are administered every 8 hours or TID per the discretion of the treating investigator. Normal saline will be administered at a total volume of 15mL.
intervention type: Drug
intervention name: Tranexamic Acid
description: IV medication administered after patient meets inclusion/exclusion criteria
arm group label: Tranexamic Acid
other name: TXA
intervention type: Drug
intervention name: Normal saline
description: IV medication administered after patient meets inclusion/exclusion criteria
arm group label: Placebo
other name: NS
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
last name: Meghan McCormick, MD
role: Principal Investigator
affiliation: UPMC Childrens Hospital of Pittsburgh
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Meghan McCormick
investigator title: Principal Investigator, Fellow
mesh term: Hemostatic Disorders
mesh term: Thrombocytopenia
mesh term: Blood Coagulation Disorders
mesh term: Tranexamic Acid
sharing ipd: Yes
ipd description: Anonymized public data set will be available after publication of primary results
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Beginning within 1 year and ending 5 years after trial completion
ipd access criteria: Researchers who provide a methodologically sound proposal may request data. Proposals should be directed to meghan.mccormick3@chp.edu. To gain access data requestors will need to sign a data access agreement.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The pre-specified analysis described in the study protocol stated the following: "For secondary endpoints, events of WHO Grade 2 or higher bleeding will be compared through the use of odds ratio or T-test statistic of means. The mean number of platelet transfusions will be analyzed using a T-test statistic of means." This analysis was not completed as it would be scientifically inappropriate due to insufficient enrollment. Instead a descriptive analysis was completed.
point of contact: 