ISRCTN73545489已完成3 期
A double blind, randomised controlled TRial EvaluAting the safety and efficacy of Tranexamic acid in patients with haematological malignancies with severe Thrombocytopenia
HS Blood and Transplant (NHSBT)0 个研究点目标入组 616 人开始时间: 2015年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 616
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31615553 protocol (added 11/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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