A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups

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

The purpose of this study is to show that a therapeutic platelet transfusion strategy (i.e. platelet transfusion only in case of bleeding) needs minimally a quarter less of transfusions compared to the standard prophylactic transfusion strategy (i.e. platelet transfusion without any sign of bleeding when the platelet count is below 10.000/µL). With the experimental transfusion strategy transfusions could be safely reduced when the study hypothesis can be proven. This is the first prospective randomized study on this topic.

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