A Trial Comparing a Prophylactic With a Therapeutic Platelet Transfusion Strategy in Two Groups
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
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) [2010]
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 [2010]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PEI 1224/01