NCT02578901: A-TREAT

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

Completed Phase 3 Results posted Last updated 26 February 2021

What this trial tests

Phase 3 trial testing Tranexamic Acid in Thrombocytopenia in 330 participants. Completed in 11 June 2020.

Timeline

1 June 2016

Primary endpoint
1 March 2020

11 June 2020

Quick facts

Lead sponsor	University of Washington
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	330
Start date	1 June 2016
Primary completion	1 March 2020
Estimated completion	11 June 2020
Sites	3 locations across United States

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →
• Placebo

Conditions studied

• Thrombocytopenia — all drugs for Thrombocytopenia →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antifibrinolytics (lysine analogues) for the prevention of bleeding in people with haematological disorders.
   Estcourt LJ, Desborough M, Brunskill SJ, Doree C, et al · · 2016 · cited 36× · PMID 26978005 · DOI 10.1002/14651858.cd009733.pub3
2. Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial.
   Gernsheimer TB, Brown SP, Triulzi DJ, Key NS, et al · · 2022 · cited 34× · PMID 35667085 · DOI 10.1182/blood.2022016308
3. The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial.
   Estcourt LJ, McQuilten Z, Powter G, Dyer C, et al · · 2019 · cited 18× · PMID 31615553 · DOI 10.1186/s13063-019-3663-2
4. How well do platelets prevent bleeding?
   Triulzi DJ. · · 2020 · cited 12× · PMID 33275687 · DOI 10.1182/hematology.2020000136
5. Alternative agents to prophylactic platelet transfusion for preventing bleeding in people with thrombocytopenia due to chronic bone marrow failure: a meta-analysis and systematic review.
   Desborough M, Hadjinicolaou AV, Chaimani A, Trivella M, et al · · 2016 · cited 11× · PMID 27797129 · DOI 10.1002/14651858.cd012055.pub2
6. Absence of hyperfibrinolysis may explain lack of efficacy of tranexamic acid in hypoproliferative thrombocytopenia.
   Ilich A, Gernsheimer TB, Triulzi DJ, Herren H, et al · · 2023 · cited 6× · PMID 36044391 · DOI 10.1182/bloodadvances.2022008255
7. Use of platelet and erythroid growth factors during induction chemotherapy for acute lymphoblastic leukaemia in a Jehovah's Witness.
   Arora N, Gupta A, Li HC, Sadeghi N. · · 2018 · cited 5× · PMID 30567199 · DOI 10.1136/bcr-2018-226497
8. Fewer severe infections with tranexamic acid in patients with hematologic malignancies.
   Poston JN, Brown SP, Ilich A, Ginsburg AS, et al · · 2024 · cited 1× · PMID 38666065 · DOI 10.1016/j.rpth.2024.102358