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American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)

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ClinicalTrials.gov Identifier: NCT02578901
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Susanne May, University of Washington

Brief Summary:
The purpose of this study is to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid (TXA) in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.

Condition or disease Intervention/treatment Phase
Thrombocytopenia Drug: Tranexamic Acid Drug: Placebo Phase 3

Detailed Description:
The purpose of this study is to conduct a prospective, randomized, blinded, placebo controlled trial to evaluate the usefulness of antifibrinolytic therapy with tranexamic acid in preventing bleeding in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy. 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tranexamic Acid (TXA)
IV or PO administered after meeting inclusion/exclusion criteria
Drug: Tranexamic Acid
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
Other Name: TXA

Placebo Comparator: Placebo
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Drug: Placebo
Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
Other Name: NS




Primary Outcome Measures :
  1. Bleeding within 30 days [ Time Frame: 30 days after activation of study drug ]
    Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.


Secondary Outcome Measures :
  1. Number of platelet transfusions [ Time Frame: 30 days after activation of study drug ]
    Number of platelet transfusions per patient during the first 30 days post prescription activation of study drug

  2. Number of days alive and without WHO grade 2 bleeding [ Time Frame: during the first 30 days post activation of study drug ]
    Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (all must be met):

  • Must be ≥ 18 years of age
  • Confirmed diagnosis of a hematologic malignancy or aplasia
  • Undergoing or planned chemotherapy, immunotherapy, or hematopoietic stem cell transplantation
  • Anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤ 10,000/microliters for ≥ 5 days
  • Able to provide informed consent and comply with treatment and monitoring, or having a Legally Authorized Representative (LAR)

Exclusion criteria (none can be present):

  • Diagnosis of acute promyelocytic leukemia undergoing induction chemotherapy
  • History of ITP, TTP or HUS
  • Subjects receiving L-asparaginase as part of their current cycle of treatment
  • Subjects with a past history or current diagnosis of arterial or venous thromboembolic disease including acute coronary syndrome, peripheral vascular disease and retinal arterial or venous thrombosis (except when a prior history of central line thrombosis has resolved)
  • Subjects with a diagnosis/previous history of sinusoidal obstruction syndrome (also called veno-occlusive disease)
  • Subjects receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) and/or an antifibrinolytic agent within 48 hours of enrollment, or with known hypercoagulable state
  • Known inherited or acquired bleeding disorder including, but not limited to:

    • Acquired storage pool deficiency
    • Paraproteinemia with platelet inhibition
  • Known inherited or acquired prothrombotic disorders, including antiphospholipid syndrome. Those with lupus anticoagulant or positive antiphospholipid serology without thrombosis are not excluded.
  • Subjects receiving anticoagulant therapy or anti-platelet therapy (except when receiving prophylactic anticoagulant or low dose aspirin therapy for prophylaxis only with a plan to discontinue when the platelet count falls below 50,000)
  • Patients with DIC according to the patient's physician
  • Subjects with WHO Grade 2 bleeding or greater within 48 hours prior to activation
  • Subjects requiring a platelet transfusion threshold > 10,000/microliters at time of randomization
  • Subjects with anuria (defined as urine output < 10mls/hr over 24 hours)
  • Subjects on dialysis
  • Subjects with creatinine ≥5.7mg/dL
  • Subjects who are pregnant or nursing or unwilling to use contraception during and for 30 days after taking the study drug (both males and females)
  • Subjects enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
  • Known allergy to tranexamic acid
  • Having been previously randomized in this study at any stage of their treatment
  • Subjects who are unwilling to accept blood or blood component transfusions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578901


Contacts
Contact: Heather Herren 800-332-0586 hherren@uw.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 21599
Contact: Nigel Key, MD       nigel_key@med.unc.edu   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Darrell Triulzi, MD       Dtriulzi@itxm.org   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Terry Gernsheimer, MD       bldbuddy@u.washington.edu   
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Terry Gernsheimer, MD University of Washington

Responsible Party: Susanne May, Professor, Biostatistics, University of Washington
ClinicalTrials.gov Identifier: NCT02578901     History of Changes
Other Study ID Numbers: STUDY00003329
1U01HL122272-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized public data set will be available after publication of primary results

Keywords provided by Susanne May, University of Washington:
Thrombocytopenia
Tranexamic Acid
TXA
Chemotherapy induced thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants