Observational Trial of a Therapeutic Platelet Transfusion Regimen
|ClinicalTrials.gov Identifier: NCT02276651|
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : October 28, 2014
Last Update Posted : June 8, 2017
|Condition or disease|
|Acute Myeloid Leukemia Thrombocytopenia|
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.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||A Prospective Multicenter Observational Trial of a Therapeutic Platelet Transfusion Regimen for Patients With Acute Myeloid Leukemia in Consolidation Chemotherapy|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 6, 2017|
|Actual Study Completion Date :||June 6, 2017|
- Bleeding Grade III and IV (WHO) [ Time Frame: Patients will be followed for the phase of thrombocytopenia after chemotherapy, an expected average of about 14 days. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276651
|Nurnberg, Germany, 90419|
|Principal Investigator:||Kerstin Schaefer-Eckart, MD||Klinikum Nürnberg|