RecruitingNCT06805097
Clinical Efficacy of Platelet Transfusion
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
343 participants
Start Date
Jun 17, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Patients with haematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to the disease or treatments received
- Severe thrombocytopenia requiring transfusion
- Patient able to self-assess bleeding events
- Non-opposition of the subject to participate in the study
- Registered with the French social security system or benefiting from such a system.
Exclusion Criteria11
- Acute promyelocytic leukaemia
- Curative dosage of anticoagulants
- Treatment with antiplatelet agents
- Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation
- Patients with a clinically significant haemorrhagic event (WHO grade 2) in the 48 hours prior to transfusion
- Indication for deplasmatised, cryopreserved and reduced-volume PCs
- Patient refusing transfusion of labile blood products
- Pregnant women or breast-feeding mothers
- Adults subject to a legal protection measure or unable to express their consent
- Persons deprived of their liberty by a judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social care institution for purposes other than research
- Subject in the exclusion period of another study
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Interventions
OTHERSelf-assessment of bleeding events
After each transfusion, the patient completes a daily bleeding event self-assessment (adapted from the WHO bleeding event scale) until the next transfusion or over a period of 10 days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06805097
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