NCT03136445

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (actual)
• Sponsor: NHS Blood and Transplant · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with cancers of the blood often develop low blood cell counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). But recent studies have indicated that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is a type of drug that is called an antifibrinolytic. These drugs act to reduce the breakdown of clots formed in response to bleeding. These drugs have been used widely in both elective and emergency surgery and have been shown to decrease blood loss and the use of red cell transfusions. 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. The investigators will measure the rates of bleeding daily using a short structured assessment of bleeding and will record the number of transfusions given to patients.

Conditions

• Hematologic Neoplasms
• Hemorrhage
• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	Tranexamic acid (TXA).	IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.
DRUG	Placebo	IV (saline) or oral placebo tablets

Timeline

• Start date: 2015-06-01
• Primary completion: 2022-02-18
• Completion: 2022-06-18
• First posted: 2017-05-02
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

27 sites across 2 countries: Australia, United Kingdom