TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NHS Blood and Transplant
• Collaborators: Monash University; National Health and Medical Research Council, Australia
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

Patients are eligible for this trial if:

1. Aged ≥18 years of age

2. Confirmed diagnosis of a haematological malignancy

3. Undergoing chemotherapy, or chemotherapy is planned, or haematopoietic stem cell transplantation

4. Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of ≤10x10⁹/L for ≥ 5 days

5. Able to comply with treatment and monitoring

Exclusion Criteria:

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

1. 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.

2. Diagnosis of acute promyelocytic leukaemia (APML) and undergoing induction chemotherapy

3. Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)

4. Patients with known inherited or acquired prothrombotic disorders e.g.

1. Lupus anticoagulant

2. Positive antiphospholipids

5. 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

6. Patients receiving L-asparaginase as part of their current cycle of treatment

7. History of immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS)

8. Patients with overt disseminated intravascular coagulation (DIC) (See Appendix 3 in the protocol for definition)

9. Patients requiring a platelet transfusion threshold >10x10/⁹L at time of randomisation. (This refers to patients who require their platelet count to be maintained at a certain specified level on an ongoing basis, and excludes a transient rise in the threshold due to sepsis.)

10. Patients with a known inherited or acquired bleeding disorder e.g.

1. Acquired storage pool deficiency

2. Paraproteinaemia with platelet inhibition

11. Patients receiving anticoagulant therapy or anti-platelet therapy

12. Patients with visible haematuria at time of randomisation

13. Patients with anuria (defined as urine output < 10 mls/hr over 24 hours).

14. Patients with severe renal impairment (eGFR ≤30 ml/min/1.73m²)

15. Patients with a previous history of epilepsy, convulsions, fits or seizures

16. Patients who are pregnant or breast-feeding

17. Allergic to tranexamic acid.

18. Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.

19. Patients previously randomised into this trial at any stage of their treatment.