<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/NCT04448184</url>
  </required_header>
  <id_info>
    <org_study_id>2068</org_study_id>
    <nct_id>NCT04448184</nct_id>
  </id_info>
  <brief_title>Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)</brief_title>
  <acronym>PATH</acronym>
  <official_title>Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alberta Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid&#xD;
      (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than&#xD;
      prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem&#xD;
      cell transplantation (ASCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are&#xD;
      performed annually for hematologic malignancies. It is currently standard practice to provide&#xD;
      a prophylactic transfusion of platelets to prevent bleeding when the daily measured platelet&#xD;
      count is less than 10 x 109/L. A patient may require up to six adult platelet doses during&#xD;
      the post-transplant period. However, the true benefit of prophylactic platelet transfusions&#xD;
      in the ASCT setting is unclear and has been called into question by several recent studies.&#xD;
&#xD;
      Prophylactic platelet transfusions may not only be unnecessary, they may be detrimental to&#xD;
      the patient. Among blood products, platelet transfusions are associated with the highest risk&#xD;
      of both infectious and non-infectious complications: this would include bacterial infections&#xD;
      and allergic /febrile reactions. Moreover, the potential overuse of platelet products places&#xD;
      a significant burden on a scarce health care resource that is provided through volunteer&#xD;
      donations.&#xD;
&#xD;
      An alternative strategy to prevent bleeding and reduce the need for platelet transfusions&#xD;
      involves administering Tranexamic Acid, an antifibrinolytic agent to stabilize blood clots&#xD;
      and reduce bleeding. Tranexamic Acid is safe and effective in many clinical scenarios, and&#xD;
      may be a reasonable alternative for prophylactic platelet transfusions. In the setting of&#xD;
      ASCT, Tranexamic Acid may reduce bleeding and further enhance a strategy of therapeutic&#xD;
      platelet transfusions where platelets are administered only in the event of active bleeding&#xD;
      symptoms.&#xD;
&#xD;
      The effect of prophylactic platelet transfusions and Tranexamic Acid on clinical, quality of&#xD;
      life and economic outcomes in patients receiving ASCT is unknown. The primary aim of this&#xD;
      research program is to perform a randomized controlled trial to determine whether a strategy&#xD;
      of prophylactic Tranexamic Acid (with therapeutic platelet transfusions) is safe and&#xD;
      effective compared to prophylactic platelet transfusions in patients undergoing ASCT.&#xD;
&#xD;
      A pilot trial demonstrated feasibility by successfully recruiting 100 patients and these&#xD;
      patients will be rolled over into the phase III study. The treatment assignment and bleeding&#xD;
      outcomes for these patients remain blinded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 16, 2022</start_date>
  <completion_date type="Anticipated">February 2027</completion_date>
  <primary_completion_date type="Anticipated">February 2027</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WHO (World Health Organization) bleeding events of Grade 2 or higher</measure>
    <time_frame>Daily, up to 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>WHO bleeding events of Grade 3 or 4</measure>
    <time_frame>Daily, up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from randomization to bleeding of WHO events Grade 2 or higher</measure>
    <time_frame>Daily, up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with bleeding of WHO bleeding events Grade 2 or higher</measure>
    <time_frame>Daily, up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher</measure>
    <time_frame>Daily, up to 30 days</time_frame>
    <description>The BSMS scale measures bleeding grade and classification from 0-2. 0 indicates no bleeding. Grade 1 bleeding consists of trace bleeding and mild bleeding and is not clinically significant. Grade 2 bleeding consists of serious bleeding, serious bleeding causing significant morbidity, and fatal bleeding. Grade 2 bleeding is clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of platelet and/or red blood cell transfusions</measure>
    <time_frame>Daily, up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions related to tranexamic acid</measure>
    <time_frame>Daily, up to 30 days.</time_frame>
    <description>Number and type of reactions will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous thromboembolism grade 2 or higher</measure>
    <time_frame>Daily, up to 30 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions related to platelet transfusion</measure>
    <time_frame>Daily, up to 30 days.</time_frame>
    <description>Number and type of reactions will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to platelet count recovery</measure>
    <time_frame>Daily, up to 30 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with a platelet count &lt; 10 x 109/L</measure>
    <time_frame>Daily, up to 30 days.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LOS (Length of hospital stay)</measure>
    <time_frame>LOS will be measured as the number of days elapsed between hospital admission and hospital discharge date up to 30 days.</time_frame>
    <description>LOS = admission date - discharge date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant related outcome: Bearman Scoring System for Organ Toxicity following HSCT</measure>
    <time_frame>Day 30</time_frame>
    <description>This is a validated scoring system to assess toxicity during HSCT. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. Regimen-related toxicity in each organ system was scored as the highest grade achieved in that organ system through day 28, except that deaths occurring after day 28 as a result of regimen-related toxicity occurring before day 28 are also scored as grade 4. Adverse events that could be attributed to infection (culture-documented), bleeding or other medications are not scored as regimen-related toxicity. The maximum toxicity is the highest grade recorded in any individual organ system and the cumulative toxicity score is the sum of the highest grades recorded for all eight organ systems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant related outcome: Incidence of infections at Day 30 following ASCT</measure>
    <time_frame>Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant related outcome: Mortality at Day 30 and 180</measure>
    <time_frame>Day 30, Day 180</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic Analyses</measure>
    <time_frame>5 years</time_frame>
    <description>Incremental cost effectiveness ratios</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measure: FACT-Thrombocytopenia 18</measure>
    <time_frame>Weekly, up to 30 days</time_frame>
    <description>The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to transplant patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measure: FACT- BMT</measure>
    <time_frame>Day 30, Day 90, Day 180</time_frame>
    <description>The FACT-BMT scale is valid and sensitive to clinical change in transplant recipients. It is the most consistently used scale amongst the Canadian Bone Marrow Transplant Group (CBMTG). It is the preferred scale in several Canadian multicentre trials in stem cell transplantation. FACT- Thrombocytopenia 18 is valid measure to elicit quality of life due to thrombocytopenia, and will complement the FACT-BMT scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measure: GAD-7</measure>
    <time_frame>Weekly, up to 30 days</time_frame>
    <description>GAD-7 is a short validated scale that assesses symptoms of generalized anxiety and is commonly used in medical settings. There is no specific validated scale to assess anxiety of patients who are at risk for bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measure: EQ-5D</measure>
    <time_frame>Weekly, up to 30 days</time_frame>
    <description>EQ-5D is a standardized measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. It is applicable to a wide range of health conditions and treatments; it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care. It is cognitively undemanding, taking only a few minutes to complete.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">662</enrollment>
  <condition>Hematologic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Prophylactic Platelet Transfusion</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prophylactic Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.&#xD;
Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions. Subjects unable to swallow oral Tranexamic Acid pills may have the tablets crushed, administered via nasogastric (NG) tube or the medication will be administered intravenously.</description>
    <arm_group_label>Prophylactic Tranexamic Acid</arm_group_label>
    <other_name>SteriMax Inc.</other_name>
    <other_name>Cyclokapron®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults 18 years or older undergoing ASCT for a hematologic malignancy&#xD;
&#xD;
          2. Patients providing written informed consent prior to starting transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A previous WHO grade 2, 3 or 4 bleeding event within the past year&#xD;
&#xD;
          2. A previous or current unprovoked thrombotic event defined as a pulmonary embolism,&#xD;
             deep vein thrombosis, cerebral thrombosis&#xD;
&#xD;
          3. A current provoked thrombotic event (e.g. catheter-related thrombosis) within last&#xD;
             month and/or still requiring anticoagulant treatment.&#xD;
&#xD;
          4. A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT&#xD;
&#xD;
          5. Active angina (chest pain of presumed cardiac origin either at rest or with activity)&#xD;
&#xD;
          6. Current or previous (within 2 weeks) urinary tract bleeding&#xD;
&#xD;
          7. An inherited hemostatic or thrombotic disorder&#xD;
&#xD;
          8. Coagulopathy defined as a prothrombin time '/International Normalization Ratio (INR)&#xD;
             or activated partial thromboplastin time more than 1.5 times the upper limit of normal&#xD;
             or fibrinogen less than 2 g/L&#xD;
&#xD;
          9. Previously documented history of refractoriness to platelet transfusion secondary to&#xD;
             HLA antibodies (Refractoriness is defined as 2 consecutive ABO matched platelet&#xD;
             transfusions with platelet increment of &lt; 7.5 and the presence of anti-HLA antibodies)&#xD;
&#xD;
         10. Significant renal impairment (creatinine more than 1.5 times the upper limit of normal&#xD;
             or a eGFR less than 0.5 mL/min/1.78m2)&#xD;
&#xD;
         11. Pregnant or breast-feeding&#xD;
&#xD;
         12. Unwilling or unable to provide informed consent&#xD;
&#xD;
         13. Participant has acquired disturbances to his/her colour vision (does not apply to&#xD;
             congenital colour blindness)&#xD;
&#xD;
         14. Participant has known sensitivity or allergy to Tranexamic Acid or any of its&#xD;
             ingredients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sohail Robert, RN</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>71892</phone_ext>
    <email>sorobert@ohri.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alan Tinmouth, MD</last_name>
    <phone>613-737-8899</phone>
    <phone_ext>73914</phone_ext>
    <email>atinmouth@ohri.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jason Tay, MD</last_name>
      <phone>403-944-1880</phone>
      <email>Jason.Tay@ahs.ca</email>
    </contact>
    <investigator>
      <last_name>Jason Tay, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christopher Venner, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Eastern Regional Health Authority</name>
      <address>
        <city>Saint John's</city>
        <state>Newfoundland and Labrador</state>
        <zip>A1B 3V6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Jones, MD</last_name>
      <email>Davidm.jones@easternhealth.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial University</name>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kirsty Tompkins, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mahmood El-Sawy, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Juravinski Hospital and Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Irwin Walker, MD</last_name>
      <phone>905 521-2100</phone>
      <phone_ext>76384</phone_ext>
      <email>walkeri@mcmaster.ca</email>
    </contact>
    <investigator>
      <last_name>Irwin Walker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anargyros Xenocostas, MD</last_name>
      <phone>519-685-8500</phone>
      <phone_ext>58631</phone_ext>
      <email>Anargyros.Xenocostas@lhsc.on.ca</email>
    </contact>
    <investigator>
      <last_name>Anargyros Xenocostas, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan Tinmouth, MD</last_name>
      <phone>613-737-8899</phone>
      <phone_ext>73914</phone_ext>
      <email>atinmouth@ohri.ca</email>
    </contact>
    <investigator>
      <last_name>Alan Tinmouth, MD MSc RCPSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawn Maze, MD, MSc</last_name>
      <phone>416-946-4501</phone>
      <phone_ext>4521</phone_ext>
      <email>dawn.maze@uhn.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuve-Rosemont</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Silvy Lachance, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saskatchewan Cancer Agency</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Elementary, MD</last_name>
      <email>mohamed.elemary@saskcancer.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04448184
org study id: 2068
nct id: NCT04448184
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid
      (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than
      prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem
      cell transplantation (ASCT).
In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are
      performed annually for hematologic malignancies. It is currently standard practice to provide
      a prophylactic transfusion of platelets to prevent bleeding when the daily measured platelet
      count is less than 10 x 109/L. A patient may require up to six adult platelet doses during
      the post-transplant period. However, the true benefit of prophylactic platelet transfusions
      in the ASCT setting is unclear and has been called into question by several recent studies.

      Prophylactic platelet transfusions may not only be unnecessary, they may be detrimental to
      the patient. Among blood products, platelet transfusions are associated with the highest risk
      of both infectious and non-infectious complications: this would include bacterial infections
      and allergic /febrile reactions. Moreover, the potential overuse of platelet products places
      a significant burden on a scarce health care resource that is provided through volunteer
      donations.

      An alternative strategy to prevent bleeding and reduce the need for platelet transfusions
      involves administering Tranexamic Acid, an antifibrinolytic agent to stabilize blood clots
      and reduce bleeding. Tranexamic Acid is safe and effective in many clinical scenarios, and
      may be a reasonable alternative for prophylactic platelet transfusions. In the setting of
      ASCT, Tranexamic Acid may reduce bleeding and further enhance a strategy of therapeutic
      platelet transfusions where platelets are administered only in the event of active bleeding
      symptoms.

      The effect of prophylactic platelet transfusions and Tranexamic Acid on clinical, quality of
      life and economic outcomes in patients receiving ASCT is unknown. The primary aim of this
      research program is to perform a randomized controlled trial to determine whether a strategy
      of prophylactic Tranexamic Acid (with therapeutic platelet transfusions) is safe and
      effective compared to prophylactic platelet transfusions in patients undergoing ASCT.

      A pilot trial demonstrated feasibility by successfully recruiting 100 patients and these
      patients will be rolled over into the phase III study. The treatment assignment and bleeding
      outcomes for these patients remain blinded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: WHO (World Health Organization) bleeding events of Grade 2 or higher
time frame: Daily, up to 30 days
measure: WHO bleeding events of Grade 3 or 4
time frame: Daily, up to 30 days
measure: Time from randomization to bleeding of WHO events Grade 2 or higher
time frame: Daily, up to 30 days
measure: Number of days with bleeding of WHO bleeding events Grade 2 or higher
time frame: Daily, up to 30 days
measure: Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher
time frame: Daily, up to 30 days
description: The BSMS scale measures bleeding grade and classification from 0-2. 0 indicates no bleeding. Grade 1 bleeding consists of trace bleeding and mild bleeding and is not clinically significant. Grade 2 bleeding consists of serious bleeding, serious bleeding causing significant morbidity, and fatal bleeding. Grade 2 bleeding is clinically significant.
measure: Number of platelet and/or red blood cell transfusions
time frame: Daily, up to 30 days
measure: Adverse reactions related to tranexamic acid
time frame: Daily, up to 30 days.
description: Number and type of reactions will be recorded.
measure: Venous thromboembolism grade 2 or higher
time frame: Daily, up to 30 days.
measure: Adverse reactions related to platelet transfusion
time frame: Daily, up to 30 days.
description: Number and type of reactions will be recorded.
measure: Time to platelet count recovery
time frame: Daily, up to 30 days.
measure: Number of days with a platelet count < 10 x 109/L
time frame: Daily, up to 30 days.
measure: LOS (Length of hospital stay)
time frame: LOS will be measured as the number of days elapsed between hospital admission and hospital discharge date up to 30 days.
description: LOS = admission date - discharge date
measure: Transplant related outcome: Bearman Scoring System for Organ Toxicity following HSCT
time frame: Day 30
description: This is a validated scoring system to assess toxicity during HSCT. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. Regimen-related toxicity in each organ system was scored as the highest grade achieved in that organ system through day 28, except that deaths occurring after day 28 as a result of regimen-related toxicity occurring before day 28 are also scored as grade 4. Adverse events that could be attributed to infection (culture-documented), bleeding or other medications are not scored as regimen-related toxicity. The maximum toxicity is the highest grade recorded in any individual organ system and the cumulative toxicity score is the sum of the highest grades recorded for all eight organ systems.
measure: Transplant related outcome: Incidence of infections at Day 30 following ASCT
time frame: Day 30
measure: Transplant related outcome: Mortality at Day 30 and 180
time frame: Day 30, Day 180
measure: Economic Analyses
time frame: 5 years
description: Incremental cost effectiveness ratios
measure: Quality of Life Measure: FACT-Thrombocytopenia 18
time frame: Weekly, up to 30 days
description: The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to transplant patients.
measure: Quality of Life Measure: FACT- BMT
time frame: Day 30, Day 90, Day 180
description: The FACT-BMT scale is valid and sensitive to clinical change in transplant recipients. It is the most consistently used scale amongst the Canadian Bone Marrow Transplant Group (CBMTG). It is the preferred scale in several Canadian multicentre trials in stem cell transplantation. FACT- Thrombocytopenia 18 is valid measure to elicit quality of life due to thrombocytopenia, and will complement the FACT-BMT scale.
measure: Quality of Life Measure: GAD-7
time frame: Weekly, up to 30 days
description: GAD-7 is a short validated scale that assesses symptoms of generalized anxiety and is commonly used in medical settings. There is no specific validated scale to assess anxiety of patients who are at risk for bleeding.
measure: Quality of Life Measure: EQ-5D
time frame: Weekly, up to 30 days
description: EQ-5D is a standardized measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. It is applicable to a wide range of health conditions and treatments; it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care. It is cognitively undemanding, taking only a few minutes to complete.
arm group label: Prophylactic Platelet Transfusion
arm group type: No Intervention
description: Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.
arm group label: Prophylactic Tranexamic Acid
arm group type: Experimental
description: Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.
intervention type: Drug
intervention name: Tranexamic Acid
description: Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.
Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions. Subjects unable to swallow oral Tranexamic Acid pills may have the tablets crushed, administered via nasogastric (NG) tube or the medication will be administered intravenously.
arm group label: Prophylactic Tranexamic Acid
other name: SteriMax Inc.
other name: Cyclokapron®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sohail Robert, RN
phone: 613-737-8899
phone ext: 71892
email: sorobert@ohri.ca
last name: Alan Tinmouth, MD
phone: 613-737-8899
phone ext: 73914
email: atinmouth@ohri.ca
facility: 
status: Recruiting
contact: 
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facility: 
status: Not yet recruiting
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facility: 
status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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status: Not yet recruiting
contact: 
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status: Recruiting
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country: Canada
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
mesh term: Tranexamic Acid