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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00521664
First received: August 27, 2007
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Myeloid Leukemia
Biological: Prophylactic platelet transfusion
Biological: Therapeutic platelet transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - 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 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: September 2004
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • patients with pulmonal or cerebral lesions due to infection or neoplasm
  • patients with al-amyloidosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521664

Locations
Germany
Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik
Nürnberg, Germany, 90419
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Gerhard Ehninger, Prof. University Hospital Carl Gustav Carus Dresden
  More Information

Additional Information:
No publications provided by Technische Universität Dresden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katrin Peschel, Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00521664     History of Changes
Other Study ID Numbers: PEI 1224/01
Study First Received: August 27, 2007
Last Updated: May 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014