Observational Trial of a Therapeutic Platelet Transfusion Regimen
- Conditions
- Acute Myeloid LeukemiaThrombocytopenia
- Registration Number
- NCT02276651
- Lead Sponsor
- Klinikum Nürnberg
- Brief Summary
Application of a therapeutic platelet transfusion Regimen in patients with acute myeloid leukemia in complete Remission (consolidation therapy)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- Acute myeloid leukemia in complete remission
- plasmatic coagulopathy
- history of severe bleeding complications in chemotherapy induced thrombocytopenia
- no increment in platelets after platelet transfusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bleeding Grade III and IV (WHO) Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum Nurnberg
🇩🇪Nurnberg, Germany