A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups
This study has been completed.
Sponsor:
Dresden University of Technology
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
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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 Dresden University of Technology:
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
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
Dresden University of Technology
Investigators
| Principal Investigator: | Gerhard Ehninger, Prof. | University Hospital Carl Gustav Carus Dresden |
More Information
Additional Information:
No publications provided by Dresden University of Technology
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 Dresden University of Technology:
|
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 May 21, 2013