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

Primary Purpose

Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombocytopenia focused on measuring Thrombocytopenia, Tranexamic Acid, TXA, Chemotherapy induced thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina
  • University of Pittsburgh
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic Acid (TXA)

Placebo

Arm Description

IV or PO administered after meeting inclusion/exclusion criteria

IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria

Outcomes

Primary Outcome Measures

Bleeding Within 30 Days
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

Number of Platelet Transfusions
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
Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug

Full Information

First Posted
October 15, 2015
Last Updated
February 26, 2021
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02578901
Brief Title
American Trial Using Tranexamic Acid in Thrombocytopenia
Acronym
A-TREAT
Official Title
American Trial Using Tranexamic Acid in Thrombocytopenia (A-TREAT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
Thrombocytopenia, Tranexamic Acid, TXA, Chemotherapy induced thrombocytopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid (TXA)
Arm Type
Active Comparator
Arm Description
IV or PO administered after meeting inclusion/exclusion criteria
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV Normal Saline or PO placebo pills administered after meeting inclusion/exclusion criteria
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NS
Intervention Description
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
Primary Outcome Measure Information:
Title
Bleeding Within 30 Days
Description
Proportion of patients with bleeding of WHO grade 2 or above, over the study period of 30 days after activation of study drug.
Time Frame
30 days after activation of study drug
Secondary Outcome Measure Information:
Title
Number of Platelet Transfusions
Description
Number of platelet transfusions per patient during the first 30 days post prescription activation of study drug
Time Frame
30 days after activation of study drug
Title
Number of Days Alive and Without WHO Grade 2 Bleeding
Description
Number of days alive and without WHO grade 2 bleeding or greater during the first 30 days post activation of study drug
Time Frame
during the first 30 days post activation of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Gernsheimer, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
21599
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized public data set will be available after publication of primary results
IPD Sharing 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.
IPD Sharing Access Criteria
The access criteria will be according to NHLBI biolincc protocols at the time of the request.
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/home/

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American Trial Using Tranexamic Acid in Thrombocytopenia

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