Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloid Leukemia | Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic platelet transfusion | Biological | — | UNRESOLVED |
| Therapeutic platelet transfusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- 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.
- interventionNames
- Biological: Therapeutic platelet transfusion
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 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.
- interventionNames
- Biological: Prophylactic platelet transfusion
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWandt 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. PMID 22877506