Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)
研究概览
简要总结
The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.
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
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML project
- •inclusion in studies of the DSIL or OSHO group for AML
- •AML M3/M3v can be included only when in complete remission
- •age 16 - 80 years
- •written informed consent
- •Autologous project
- •AMl and ALL patients in first or second remission
- •low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma
- •conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or a similarly intensive chemotherapy regime
- •age 16 - 65 years
排除标准
- •AML project
- •known refractoriness to platelet transfusion
- •known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
- •known plasmatic coagulation disorder
- •patient unable to give informed consent
- •Autologous project
- •known refractoriness to platelet transfusion
- •known major bleeding with thrombocytopenia when the reason for bleeding is still ongoing
- •known plasmatic coagulation disorder
- •patient unable to give informed consent
- •patients with pulmonal or cerebral lesions due to infection or neoplasm
- •patients with al-amyloidosis
研究组 & 干预措施
1
Therapeutic platelet transfusion (TP) strategy versus prophylactic platelet transfusion (PP) strategy. In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.
干预措施: Therapeutic platelet transfusion (Biological)
2
In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.
干预措施: Prophylactic platelet transfusion (Biological)
结局指标
主要结局
reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)
时间窗: 2010
次要结局
- - incidence and duration of clinically relevant bleeding - numbers of red blood cell transfusion - side effects of transfusions - duration of thrombocytopenia below 10.000/µL and below 20.000/µL - duration of hospitalisation(2010)