Symptoms and General Pathology

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Blood and Lymph Conditions

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Hemorrhage

Thrombocytopenia

Hematologic Neoplasms

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Coagulants

All Drugs and Chemicals

Tranexamic Acid

Antifibrinolytic Agents

Hemostatics

Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.

Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.

IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.

Tranexamic acid (TXA).

Placebo

Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath

Zoe K McQuilten, MBBS PhD

Simon J Stanworth, DPhil FRCP FRCPath

Erica M Wood, MB BS, FRACP, FRCPA

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.

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.

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

The datasets generated during and/or analysed during the current study will be available upon request from the NHSBT Clinical Trials Unit after de-identification (text, tables, figures and appendices) 9 months after publication and ending 5 years following article publication.

Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.

Reasons for platelet and red cell transfusions as documented by clinician.

The proportion of patients who die or have bleeding of WHO grade 2 or above by WHO criteria during the first 30 days from the first dose of trial treatment, or planned first dose for those participants who do not receive treatment.

A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.

Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.

Bleeding assessed using WHO bleeding criteria.

Measured by number of recorded platelet transfusions per patient.

Measured by number of recorded red cell transfusions per patient.

Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.

Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.

Measured by calculating number of clinically diagnosed thrombotic events from Treatment Day 1 i.e the first day that the investigational medicinal product (IMP) is administered, up to and including the next 120 days.

Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths in first 30 days and 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths due to thrombosis during the first 120 days after Treatment Day 1 i.e the first day that the IMP is administered.

Measured by calculating number of deaths due to bleeding during the first 30 days

Measured by calculating the total number of SAE's reported from first administration of IMP.

Spots Global Cancer Trial Database for tranexamic acid (txa).