Abstract | BACKGROUND: METHODS: This is a multinational randomised, double-blind, placebo-controlled, parallel, superiority trial. Patients will be randomly assigned to receive tranexamic acid (given intravenously or orally) or a matching placebo in a 1:1 ratio, stratified by site. Patients with haematological malignancies receiving intensive chemotherapy or stem cell transplantation (or both) who are at least 18 years of age and expected to become severely thrombocytopenic for at least 5 days will be eligible for this trial. The primary outcome of the trial is the proportion of patients who died or had bleeding of World Health Organization grade 2 or above during the first 30 days of the trial. We will measure the rates of bleeding daily by using a short, structured assessment of bleeding, and we will record the number of transfusions given to patients. We will assess the risk of arterial and venous thrombosis for 120 days from the start of trial treatment. DISCUSSION: TRIAL REGISTRATION: This study was prospectively registered on Current Controlled Trials on 25 March 2015 (ISRCTN73545489) and is also registered on ClinicalTrials.gov (NCT03136445).
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Authors | Lise J Estcourt, Zoe McQuilten, Gillian Powter, Claire Dyer, Eleanor Curnow, Erica M Wood, Simon J Stanworth, TREATT Trial Collaboration (provisional) |
Journal | Trials
(Trials)
Vol. 20
Issue 1
Pg. 592
(Oct 15 2019)
ISSN: 1745-6215 [Electronic] England |
PMID | 31615553
(Publication Type: Clinical Trial Protocol, Journal Article)
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Chemical References |
- Antifibrinolytic Agents
- Tranexamic Acid
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Topics |
- Administration, Intravenous
- Administration, Oral
- Antifibrinolytic Agents
(administration & dosage, adverse effects)
- Australia
- Double-Blind Method
- Fibrinolysis
(drug effects)
- Hematologic Neoplasms
(complications, mortality, therapy)
- Hemorrhage
(blood, etiology, mortality, prevention & control)
- Humans
- Multicenter Studies as Topic
- Prospective Studies
- Randomized Controlled Trials as Topic
- Severity of Illness Index
- Thrombocytopenia
(blood, drug therapy, etiology, mortality)
- Tranexamic Acid
(administration & dosage, adverse effects)
- Treatment Outcome
- United Kingdom
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