EUCTR2014-001513-35-GB进行中（未招募）1 期
TREATT: TRial to EvaluAte Tranexamic acid therapy in ThrombocytopeniaA double blind, randomised controlled trial evaluating the safety and efficacy of Tranexamic acid in patients with haematological malignancies with severe thrombocytopenia. - Antifibrinolytics for haematology patients. Version 1.1
HS Blood and Transplant.0 个研究点目标入组 616 人开始时间: 2019年7月2日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 616
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 616
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •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. Patints 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 enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
- •16. Allergic to tranexamic acid or epsilon amino caproic acid
- •17. Previously randomised in this study at any stage of their treatment
研究者
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