American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02578901 |
Recruitment Status :
Completed
First Posted : October 19, 2015
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Thrombocytopenia | Drug: Tranexamic Acid Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 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) |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | June 11, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tranexamic Acid (TXA)
IV or PO administered after meeting inclusion/exclusion criteria
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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 |
- 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.
- 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
- 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 |
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
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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

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
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 21599 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Terry Gernsheimer, MD | University of Washington |
Documents provided by Susanne May, University of Washington:
Responsible Party: | Susanne May, Professor, Biostatistics, University of Washington |
ClinicalTrials.gov Identifier: | NCT02578901 |
Other Study ID Numbers: |
STUDY00003329 1U01HL122272-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | October 19, 2015 Key Record Dates |
Results First Posted: | March 24, 2021 |
Last Update Posted: | March 24, 2021 |
Last Verified: | February 2021 |
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 |
Time Frame: | Public use data will be available within 3 years after primary outcome completion. These will be available through NHLBI and the duration of their availability will be according to NHLBI biolincc protocols. |
Access Criteria: | The access criteria will be according to NHLBI biolincc protocols at the time of the request. |
URL: | https://biolincc.nhlbi.nih.gov/home/ |
Thrombocytopenia Tranexamic Acid TXA Chemotherapy induced thrombocytopenia |
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Tranexamic Acid Antifibrinolytic Agents |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |