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Observational Trial of a Therapeutic Platelet Transfusion Regimen

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状态已终止
赞助商
Klinikum Nürnberg
合作者
Technische Universität Dresden
University Hospital Heidelberg
Klinikum Chemnitz gGmbH
University Medicine Greifswald

关键词

抽象

Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)

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

Acute Myeloid Leukemia
Thrombocytopenia

-

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
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.]

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