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

Phase 3

Completed

• Conditions: Myeloid Leukemia
• Interventions: Biological: Therapeutic platelet transfusion; Biological: Prophylactic platelet transfusion

• Registration Number: NCT00521664
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-28
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Therapeutic platelet transfusion	Therapeutic platelet transfusion (TP) strategy versus prophylactic platelet transfusion (PP) strategy. 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.
2	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.

Primary Outcome Measures

Name	Time	Method
reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)	2010

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (1)

Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik; 🇩🇪 Nürnberg, Germany