Antifibrinolytics for haematology patients. Version 1.0
Research type
Research Study
Full title
TREATT: TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia A double blind, randomised controlled trial evaluating the safety and efficacy of Tranexamic acid in patients with haematological malignancies with severe thrombocytopenia.
IRAS ID
141516
Contact name
Nicholas Watkins
Contact email
Sponsor organisation
NHS Blood and Transplant.
Eudract number
2014-001513-35
Research summary
Patients with blood cancers (e.g. leukaemia and lymphoma) are at high risk of bleeding due to the disease or its treatment. Platelet transfusions are given to these patients to prevent bleeding. However, despite this, nearly half of all patients receiving intensive chemotherapy or a stem cell transplant experience clinically significant bleeding within a 30 day period.
This study's aim is to assess whether tranexamic acid (a drug that helps to stabilise blood clots) reduces bleeding in patients with blood cancers receiving intensive chemotherapy or a stem cell transplant. Important secondary outcomes are: whether this treatment is safe (does not increase risk of a blood clot in the leg or lung); whether this reduction in bleeding leads to a significant decrease in platelet component use.
This will be a study in adult patients who are being cared for at haematology centres in the UK and Australia. Patients will receive the study treatment (tranexamic acid or placebo) when their platelet count is very low.REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/1290
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion