Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Level of amplitude observed in thromboelastography
研究概览
简要总结
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.
详细描述
Patients with hematological malignancies often develop low platelet 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). The last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. The purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated to a social security regimen or beneficiary of the same
- •Signed written informed consent form
- •Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy
- •Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days
排除标准
- •Pregnant women
- •Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
- •Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free)
- •Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment
- •Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state
- •Diagnosis of arterial or venous thromboembolic disease within the previous year
- •Patient experiencing a bleeding event WHO grade ≥ 2 within 7 days before inclusion
- •contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance < 30 mL/min)
- •Refusing participation
研究组 & 干预措施
Tranexamic acid 3g/day
Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
干预措施: Tranexamic acid (Drug)
Tranexamic acid 1.5g/day
Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Level of amplitude observed in thromboelastography
时间窗: 30 days
Amplitude levels observed in thromboelastography will be reported
次要结局
- Percentage of lysis after 30min(30 minutes)
- Alpha angle(30 days)
- Time at the beginning of the clot(30 minutes)
- Clot formation time(30 minutes)
- Number of adverse events(3 months)
- Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above(30 days)