NCT00521664

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloid Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Prophylactic platelet transfusion	In the PP arm platelet transfusion has to be performed when platelet count is below 10.000/µL in any case and when bleeding (more than petechial) occurs.
BIOLOGICAL	Therapeutic platelet transfusion	In the TP arm platelet transfusion is only required if bleeding occurs (more than petechial)or in case of pulmonary infections with or without sepsis.

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-08-28
• Last updated: 2011-05-19

Locations

1 site across 1 country: Germany