Observational Trial of a Therapeutic Platelet Transfusion Regimen
关键词
抽象
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.
日期
最后验证: | 05/31/2017 |
首次提交: | 10/21/2014 |
提交的预估入学人数: | 10/26/2014 |
首次发布: | 10/27/2014 |
上次提交的更新: | 06/06/2017 |
最近更新发布: | 06/07/2017 |
实际学习开始日期: | 10/31/2014 |
预计主要完成日期: | 06/05/2017 |
预计完成日期: | 06/05/2017 |
状况或疾病
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Acute myeloid leukemia in complete remission Exclusion Criteria: - plasmatic coagulopathy - history of severe bleeding complications in chemotherapy induced thrombocytopenia - no increment in platelets after platelet transfusion |
结果
主要结果指标
1. Bleeding Grade III and IV (WHO) [Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.]