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

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00521664
First received: August 27, 2007
Last updated: May 18, 2011
Last verified: May 2011
History of Changes

August 27, 2007
May 18, 2011
September 2004
September 2010   (final data collection date for primary outcome measure)
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 ]
reduction in numbers of platelet transfusion by 25 % in the experimental arm (therapeutic transfusion strategy)compared with the standard arm (prophylactic transfusion strategy)
Complete list of historical versions of study NCT00521664 on ClinicalTrials.gov Archive Site
- 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 ]
- 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
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myeloid Leukemia
  • 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.
  • 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.
    Intervention: Biological: Therapeutic platelet transfusion
  • 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.
    Intervention: Biological: Prophylactic platelet transfusion
Wandt H, Schaefer-Eckart K, Wendelin K, Pilz B, Wilhelm M, Thalheimer M, Mahlknecht U, Ho A, Schaich M, Kramer M, Kaufmann M, Leimer L, Schwerdtfeger R, Conradi R, Dölken G, Klenner A, Hänel M, Herbst R, Junghanss C, Ehninger G; Study Alliance Leukemia. Therapeutic platelet transfusion versus routine prophylactic transfusion in patients with haematological malignancies: an open-label, multicentre, randomised study. Lancet. 2012 Oct 13;380(9850):1309-16. doi: 10.1016/S0140-6736(12)60689-8. Epub 2012 Aug 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
16 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00521664
PEI 1224/01
Yes
Katrin Peschel, Dresden University of Technology
Dresden University of Technology
Not Provided
Principal Investigator: Gerhard Ehninger, Prof. University Hospital Carl Gustav Carus Dresden
Dresden University of Technology
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP