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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myeloid Leukemia

Intervention / Treatment
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* Biological: Prophylactic platelet transfusion
* Biological: Therapeutic platelet transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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.<br>|
| Active Comparator: 2<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proof of safety and cost effectiveness of the new therapeutic platelet transfusion strategy