<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/NCT03801122</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1201</org_study_id>
    <secondary_id>2018-004756-38</secondary_id>
    <nct_id>NCT03801122</nct_id>
  </id_info>
  <brief_title>Evolution of Thromboelastography During Tranexamic Acid Treatment</brief_title>
  <acronym>TTRAP-Bleeding</acronym>
  <official_title>Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Patients with hematological malignancies are at increased risk of bleeding, especially during&#xD;
      intensive chemotherapy. The aim of this study is to compare by thromboelastography changes&#xD;
      during the intensive chemotherapy in patients with hematological malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with hematological malignancies often develop low platelet counts either as a&#xD;
      consequence of the disease or the treatment by chemotherapy or stem cell transplantation.&#xD;
      Platelet transfusions are commonly given to raise any low platelet count and reduce the risk&#xD;
      of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have&#xD;
      showed that many patients continue to experience bleeding, despite the use of platelet&#xD;
      transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots&#xD;
      formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and&#xD;
      decreases blood loss and the use of red cell transfusions. The purpose of this study is to&#xD;
      test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to&#xD;
      study its effect by thromboelastography, with the aim to determine the optimal posology for&#xD;
      further clinical studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">July 11, 2022</completion_date>
  <primary_completion_date type="Actual">March 9, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of amplitude observed in thromboelastography</measure>
    <time_frame>30 days</time_frame>
    <description>Amplitude levels observed in thromboelastography will be reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time at the beginning of the clot</measure>
    <time_frame>30 minutes</time_frame>
    <description>Time at the beginning of the clot will be reported in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clot formation time</measure>
    <time_frame>30 minutes</time_frame>
    <description>Clot formation time will ne reported in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alpha angle</measure>
    <time_frame>30 days</time_frame>
    <description>Alpha angle will be measured in degrees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of lysis after 30min</measure>
    <time_frame>30 minutes</time_frame>
    <description>Percentage of lysis after 30min will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>3 months</time_frame>
    <description>Number of adverse events will be reported</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Hematological Malignancies Treated With Intensive Chemotherapy</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid 3g/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of tranexamic acid 3g/day, with 3 injections/8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tranexamic acid 1.5g/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment (no administration of tranexamic acid)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Administration of tranexamic acid, with 3 injections/8 hours.</description>
    <arm_group_label>Tranexamic acid 1.5g/day</arm_group_label>
    <arm_group_label>Tranexamic acid 3g/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient affiliated to a social security regimen or beneficiary of the same&#xD;
&#xD;
          -  Signed written informed consent form&#xD;
&#xD;
          -  Confirmed diagnosis of a hematological malignancy and undergoing intensive&#xD;
             chemotherapy&#xD;
&#xD;
          -  Expected to experience hypoproliferative thrombocytopenia resulting in a platelet&#xD;
             count of ≤10 G/L for ≥ 5 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient under guardianship or deprived of his liberty or any condition that may affect&#xD;
             the patient's ability to understand and sign the informed consent&#xD;
&#xD;
          -  Refractoriness to platelet transfusion or requirement for a specific type of platelet&#xD;
             transfusion (ABO-compatible, plasma-free)&#xD;
&#xD;
          -  Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment&#xD;
&#xD;
          -  Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in&#xD;
             other trials involving platelet transfusions, platelet growth factors, or presentation&#xD;
             of a known hypercoagulable state&#xD;
&#xD;
          -  Diagnosis of arterial or venous thromboembolic disease within the previous year&#xD;
&#xD;
          -  Patient experiencing a bleeding event WHO grade ≥ 2 within 7 days before inclusion&#xD;
&#xD;
          -  contra-indications to tranexamic acid (allergy, history of seizures, creatinine&#xD;
             clearance &lt; 30 mL/min)&#xD;
&#xD;
          -  Refusing participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilie Chalayer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tranexamic acid</keyword>
  <keyword>bleeding</keyword>
  <keyword>hematological malignancies</keyword>
  <keyword>thrombocytopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03801122
org study id: 2018-1201
secondary id: 2018-004756-38
nct id: NCT03801122
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with hematological malignancies are at increased risk of bleeding, especially during
      intensive chemotherapy. The aim of this study is to compare by thromboelastography changes
      during the intensive chemotherapy in patients with hematological malignancies.
Patients with hematological malignancies often develop low platelet counts either as a
      consequence of the disease or the treatment by chemotherapy or stem cell transplantation.
      Platelet transfusions are commonly given to raise any low platelet count and reduce the risk
      of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have
      showed that many patients continue to experience bleeding, despite the use of platelet
      transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots
      formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and
      decreases blood loss and the use of red cell transfusions. The purpose of this study is to
      test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to
      study its effect by thromboelastography, with the aim to determine the optimal posology for
      further clinical studies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Level of amplitude observed in thromboelastography
time frame: 30 days
description: Amplitude levels observed in thromboelastography will be reported
measure: Time at the beginning of the clot
time frame: 30 minutes
description: Time at the beginning of the clot will be reported in minutes
measure: Clot formation time
time frame: 30 minutes
description: Clot formation time will ne reported in minutes
measure: Alpha angle
time frame: 30 days
description: Alpha angle will be measured in degrees
measure: Percentage of lysis after 30min
time frame: 30 minutes
description: Percentage of lysis after 30min will be measured
measure: Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above
time frame: 30 days
description: Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported
measure: Number of adverse events
time frame: 3 months
description: Number of adverse events will be reported
arm group label: Tranexamic acid 3g/day
arm group type: Experimental
description: Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
arm group label: Tranexamic acid 1.5g/day
arm group type: Experimental
description: Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
arm group label: No treatment
arm group type: No Intervention
description: No treatment (no administration of tranexamic acid)
intervention type: Drug
intervention name: Tranexamic acid
description: Administration of tranexamic acid, with 3 injections/8 hours.
arm group label: Tranexamic acid 1.5g/day
arm group label: Tranexamic acid 3g/day
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emilie Chalayer, MD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
facility: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
mesh term: Tranexamic Acid
sharing ipd: No