Clinical Efficacy of Platelet Transfusion (ECLAT)

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.

Study Overview

• Status: Recruiting
• Conditions: Haematological Malignancies; Thrombocytopaenia
• Intervention / Treatment: Other: Self-assessment of bleeding events

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.

• Study Type: Observational
• Enrollment (Estimated): 343

Contacts and Locations

• Study Contact: Name: Charline Vauchy, PhD.; Phone Number: +33381218875; Email: cvauchy@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • CHU Besançon
    • Contact: Charline Vauchy, PhD.; Phone Number: +33381218875; Email: cvauchy@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for haematological malignancy with severe thrombocytopenia associated with bone marrow failure and requiring platelet transfusion

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe thrombocytopenia; Patients with haematological malignancies who have severe thrombocytopenia associated with bone marrow failure requiring platelet transfusion and who are able to self-assess bleeding events.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 2 or higher bleeding event	Grade 2 or higher bleeding event, depending on platelet shelf life.	7 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: transfusion; haemorrhage; platelet concentrate
• Additional Relevant MeSH Terms: Cytopenia; Neoplasms by Site; Neoplasms; Hematologic Diseases; Blood Platelet Disorders; Hematologic Neoplasms; Thrombocytopenia
• Other Study ID Numbers: 2025/934

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No