Clinical Efficacy of Platelet Transfusion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Acute promyelocytic leukaemia
Curative dosage of anticoagulants
Treatment with antiplatelet agents
Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation
Trial population
Patients treated for haematological malignancy with severe thrombocytopenia associated with bone marrow failure and requiring platelet transfusion
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Self-assessment of bleeding events
Other interventionAfter 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.
Treatment groups
343 Participants
are divided into 1 treatment groupGroup A: Patients with severe thrombocytopenia1 intervention
Trial outcomes
Primary outcomes
1
Grade 2 or higher bleeding event
Grade 2 or higher bleeding event, depending on platelet shelf life.
Time frame
7 daysSponsors and contacts
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Source ClinicalTrials.gov