Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
16 Years
80 Years
Both
Myeloid Leukemia
Trial Information
Prospective Randomized Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups: 1)in Patients With Acute Myeloid Leukemia After Intensive Chemotherapy and 2) After Autologous Blood Stem Cell Transplantation
Inclusion Criteria:
AML project
- inclusion in studies of the DSIL or OSHO group for AML
- AML M3/M3v can be included only when in complete remission
- age 16 - 80 years
- written informed consent
Autologous project
- AMl and ALL patients in first or second remission
- low grade or high grade non hodgkin lymphoma or morbus hodgkin or multiple myeloma
- conditioning regime: TBI 8-12 Gy/Cy 120 or BEAM or BU/CY or Melphalan 140-200mg/m2 or
a similarly intensive chemotherapy regime
- age 16 - 65 years
Exclusion Criteria:
AML project
- known refractoriness to platelet transfusion
- known major bleeding with thrombocytopenia when the reason for bleeding is still
ongoing
- known plasmatic coagulation disorder
- patient unable to give informed consent
Autologous project
- known refractoriness to platelet transfusion
- known major bleeding with thrombocytopenia when the reason for bleeding is still
ongoing
- known plasmatic coagulation disorder
- patient unable to give informed consent
- patients with pulmonal or cerebral lesions due to infection or neoplasm
- patients with al-amyloidosis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)
Outcome Time Frame:
2010
Safety Issue:
No
Principal Investigator
Gerhard Ehninger, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Carl Gustav Carus Dresden
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
PEI 1224/01
NCT ID:
NCT00521664
Start Date:
September 2004
Completion Date:
September 2010
Related Keywords:
- Myeloid Leukemia
- proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy
- Leukemia
- Leukemia, Myeloid
Name | Location |
|---|
