NCT00521664已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
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