Trial to evaluate tranexamic acid therapy in thrombocytopenia

Phase 3

Completed

• Conditions: Patients with haematological malignancies receiving intensive chemotherapy and/or stem cell transplantation; Cancer

• Registration Number: ISRCTN73545489
• Lead Sponsor: HS Blood and Transplant (NHSBT)

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31615553 protocol (added 11/02/2020)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-25
• Study Completion: 2022-06-18
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 616

Inclusion Criteria

1. At least 18 years of age
2. Confirmed diagnosis of a haematological malignancy
3. Undergoing chemotherapy or haematopoietic stem cell transplantation
4. Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of =10x10 to the power of 9/L for = 5 days
5. Able to comply with treatment and monitoring

Exclusion Criteria

Current exclusion criteria as of 10/12/2018:
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.
4.1. Lupus anticoagulant
4.2. 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 DIC (See Appendix 3 in the protocol for definition)
9. Patients requiring a platelet transfusion threshold >10x109/L 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.
10.1. Acquired storage pool deficiency
10.2. 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 breastfeeding
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

Previous exclusion criteria:
1. Diagnosis of acute promyelocytic leukaemia and undergoing induction chemotherapy
2. History of ITP, TTP or HUS
3. Patients receiving L-asparginase as part of their current cycle of treatment
4. 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
5. Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)
6. 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
7. Known inherited or acquired bleeding disorder. E.g. acquired storage pool deficiency; paraproteinaemia with platelet inhibition; known inherited or acquired prothrombotic disorders
9. Patients receiving anticoagulant therapy or anti-platelet therapy
10. Patients with overt disseminated intravascular coagulation
11. Patients with visible haematuria at time of randomisation
12. Patients requiring a platelet transfusion threshold >10x10 to the power of 9/L at time of randomisation
13. Patients with anuria (defined as urine output < 10mls/hr over 24 hours)
14. Patients who are pregnant
15. Patients en

Study & Design

• Study Type: Interventional
• Study Design: Not specified