A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Bleeding Grade III and IV (WHO)
研究概览
简要总结
Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)
详细描述
For the participants a therapeutic regimen for platelet transfusions will be applied: for clinically stable patients platelet Transfusion will be given in case of bleeding WHO II° or higher, for clinically instable patients platelet transfusion will be given at the decretion of the attending physician.
Patients with sepsis, septic shock or infections with Infiltration of organs (e.g. invasive aspergillosis), plasmatic coagulation disorders or sudden or increasing headache with or without neurologic symptoms should receive prophylactic platelet Transfusion, if their platelet Count is less then 10/nl. Otherwise no prophylactic platelet Transfusion will be given irrespective of the actual platelet Count.
As Primary study endpoint The incidence of bleeding episodes WHO grade III an IV will be documented. The bleeding incidence will then be compared to a historic cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myeloid leukemia in complete remission
排除标准
- •plasmatic coagulopathy
- •history of severe bleeding complications in chemotherapy induced thrombocytopenia
- •no increment in platelets after platelet transfusion
结局指标
主要结局
Bleeding Grade III and IV (WHO)
时间窗: Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.
次要结局
未报告次要终点
研究者
Dr Kerstin Schäfer-Eckart
Principal Investigator
Klinikum Nürnberg