NCT06805097

Clinical Efficacy of Platelet Transfusion

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 343 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Since 2017, the preparation processes and shelf life of platelet concentrates (PCs) have been changed to increase transfusion safety and optimise transfusion processes. These changes have led to an increase in the total number of PCs transfused, a decrease in the number of platelets per PC and an increase in the number of platelets transfused per patient. Previous studies have shown that longer storage of platelets contributes to less in vivo recirculation of transfused platelets. Studies of haemostatic efficacy have generally not reported a significant effect. However, the haemostatic efficacy of PC stored for more or less than 5 days has not been evaluated. The ECLAT multicentre prognostic cohort study will prospectively and comparatively evaluate the haemorrhagic event in haematology patients with severe thrombocytopenia transfused according to the duration of PC storage.

Conditions

• Thrombocytopaenia
• Haematological Malignancies

Interventions

Type	Name	Description
OTHER	Self-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.

Timeline

• Start date: 2025-06-17
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-02-03
• Last updated: 2025-07-09

Locations

1 site across 1 country: France