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

May 18, 2011 updated by: Technische Universität Dresden

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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.
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.
Active Comparator: 2
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2010

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Gerhard Ehninger, Prof., University Hospital Carl Gustav Carus Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEI 1224/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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