drugset / Trial / NCT03136445
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
Phase 3
Completed
616 enrolled
NHS Blood and Transplant
Monash University · collabNational Health and Medical Research Council, Australia · collab
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.
Timeline
- Start
- 2015-06
- Primary completion
- 2022-02-18
- Completion
- 2022-06-18
Outcome
Missed primary endpoint
paper 31·7% (90/298 [95% CI 26·6-37·4]) in the tranexamic acid group and 34·2% (98/295 [29·0-40·0]) in the placebo group PMID 39642900 ↗
paper placebo group (hazard ratio 0·92 [95% CI 0·67-1·27]; p=0·62). PMID 39642900 ↗
Publications
- Results TREATT Trial Investigators. Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial. Lancet Haematol. 2025 Jan;12(1):e14-e22. doi: 10.1016/S2352-3026(24)00317-X. Epub 2024 Dec 3.
- Estcourt LJ, McQuilten Z, Powter G, Dyer C, Curnow E, Wood EM, Stanworth SJ; TREATT Trial Collaboration (provisional). 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. Trials. 2019 Oct 15;20(1):592. doi: 10.1186/s13063-019-3663-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |
| Subject | Tranexamic Acid | Small molecule | 1.5 g | Intravenous |