A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups
NCT ID: NCT00521664
Last Updated: 2011-05-19
Study Results
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Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2004-09-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
80 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Responsible Party
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Dresden University of Technology
Principal Investigators
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Gerhard Ehninger, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Carl Gustav Carus Dresden
Locations
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Klinikum Nürnberg Nord; Einheit für Knochenmarktransplantation; 5. Med. Klinik
Nuremberg, , Germany
Countries
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References
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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, Dolken G, Klenner A, Hanel 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.
Other Identifiers
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PEI 1224/01
Identifier Type: -
Identifier Source: org_study_id
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