Does platelet storage time affect protection from bleeding in blood cancer patients?
Clinical Efficacy of Platelet Transfusion
This project tests whether how long donated platelets are stored (about 5 days versus longer) changes bleeding risk for people with blood cancers and very low platelet counts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 343 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besançon) |
| Trial ID | NCT06805097 on ClinicalTrials.gov |
What this trial studies
Since 2017 changes in platelet preparation and shelf life have altered the number and composition of platelet concentrates transfused to patients. The ECLAT study is a prospective multicentre observational cohort that compares haemorrhagic events in haematology patients with severe thrombocytopenia according to the duration of platelet concentrate storage (shorter versus longer than 5 days). Bleeding events are recorded by patient self-assessment alongside clinical data to link transfusion characteristics with outcomes. The design focuses on real-world transfusions given for prophylaxis in patients with haematological malignancies or bone marrow aplasia.
Who should consider this trial
Good fit: Adults with haematological malignancies or bone marrow aplasia who have severe thrombocytopenia requiring prophylactic platelet transfusion, can self-report bleeding events, are covered by the French social security system, and agree to participate.
Not a fit: Patients with acute promyelocytic leukaemia, immune-mediated thrombocytopenia or disseminated intravascular coagulation, those on curative-dose anticoagulants or antiplatelet drugs, with recent significant bleeding, pregnant or breastfeeding women, or adults under legal protection are excluded and unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the findings could help blood banks and clinicians choose optimal platelet storage times to reduce bleeding and use platelets more effectively.
How similar studies have performed: Previous work shows longer platelet storage reduces in vivo recirculation but generally has not shown clear effects on haemostatic outcomes, and the specific comparison of platelets stored ≤5 days versus >5 days has not been evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Besançon
- CHU Besançon — Besançon, France (Recruiting)
Study contacts
- Study coordinator: Charline Vauchy, PhD.
- Email: cvauchy@chu-besancon.fr
- Phone: +33381218875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.