TREATT Explained

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 research has 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. We will measure the rates of bleeding daily using a short structured assessment of bleeding, and we will record the number of transfusions given to patients.

PARTICIPATION CRITERIA

Studies are designed with clearly defined inclusion and exclusion criteria, to ensure that patients are suitable for the study and any risks are minimised.  The complete inclusion/exclusion criteria are defined within the current version of the study protocol.

A brief outline of the TREATT study criteria are as follows:

Patients are eligible for this study if:

  • Aged ≥18 years of age
  • Confirmed diagnosis of a haematological malignancy
  • Undergoing chemotherapy or chemotherapy is planned or haematopoietic stem cell transplantation
  • Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of ≤10x109/L for ≥ 5 days

A patient will not be eligible for this study if he/she fulfils one or more of the following criteria:

  • Diagnosis of acute promyelocytic leukaemia and undergoing induction chemotherapy
  • Patients receiving L-asparginase as part of their current cycle of treatment
  • Patients with a past history or current diagnosis of arterial or venous thromboembolic disease including myocardial infarction, peripheral vascular disease and retinal arterial or venous thrombosis
  • Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)
  • Patients receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) within 48 hours of enrolment, or with known hypercoagulable state
  • Patients with a known inherited or acquired bleeding disorder
  • Patients with known inherited or acquired prothrombotic disorders
  • Patients receiving anticoagulant therapy or anti-platelet therapy
  • Patients with severe renal impairment
  • Patients who are pregnant or breast-feeding
  • Patients with a previous history of epilepsy, convulsions, fits or seizures
  • Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
  • Allergic to tranexamic acid.
  • Patients previously randomised into this trial at any stage of their treatment.
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