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

Technische Universität Dresden1 site in 1 country400 target enrollmentSeptember 2004

ConditionsMyeloid Leukemia

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Myeloid Leukemia
Sponsor: Technische Universität Dresden
Enrollment: 400
Locations: 1
Primary Endpoint: reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

September 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Eligibility Criteria

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

Outcomes

Primary Outcomes

reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)

Time Frame: 2010

Secondary Outcomes

- incidence and duration of clinically relevant bleeding - numbers of red blood cell transfusion - side effects of transfusions - duration of thrombocytopenia below 10.000/µL and below 20.000/µL - duration of hospitalisation(2010)