Actively Recruiting
Clinical Efficacy of Platelet Transfusion in Patients with Hematological Malignancies
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2025-07-09
343
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of how long platelet concentrates are stored on bleeding events in patients with blood cancers who need preventive platelet transfusions. The study focuses on patients with severe low platelet counts due to bone marrow failure associated with their disease or treatment. It aims to compare bleeding events based on whether platelet concentrates are stored for more or less than 5 days, as this has not been previously evaluated in detail. Participants will receive platelet transfusions as needed, and after each transfusion, they will self-assess any bleeding events daily using a scale adapted from the World Health Organization. This self-assessment continues until the next transfusion or for up to 10 days. The study is observational and does not involve experimental treatments but monitors standard transfusion practices. During the study, patients will track bleeding events to help researchers measure the occurrence of grade 2 or higher bleeding within 7 days after transfusion. The study involves regular monitoring through self-assessments, and participants must be able to perform these evaluations themselves. The study is expected to run until July 2028 and is led by a university hospital in France.
CONDITIONS
Brief Title
Clinical Efficacy of Platelet Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to disease or treatment
- Severe thrombocytopenia requiring transfusion
- Ability to self-assess bleeding events
- Non-opposition to participate in the study
- Registered with or benefiting from the French social security system
You will not qualify if you...
- Acute promyelocytic leukemia
- Use of curative doses of anticoagulants
- Treatment with antiplatelet agents
- Proven immunological thrombocytopenia or disseminated intravascular coagulation
- Clinically significant bleeding (WHO grade 2) within 48 hours before transfusion
- Need for deplasmatised, cryopreserved, or reduced-volume platelet concentrates
- Refusal of transfusion of labile blood products
- Pregnant or breastfeeding women
- Adults under legal protection or unable to consent
- Persons deprived of liberty or under compulsory psychiatric care
- Participation in exclusion period of another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 7 days after each transfusion
Participants with severe thrombocytopenia are observed for bleeding events after platelet transfusion.
Daily self-assessment of bleeding events for up to 10 days after each transfusion
Trial Site Locations
Total: 1 location
1
CHU Besançon
Besançon, France, 25000
Actively Recruiting
Research Team
C
Charline Vauchy, PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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