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NCT Number: NCT06805097

Clinical Efficacy of Platelet Transfusion

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-assessment of bleeding events

Other

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.

Primary outcomes

  1. Grade 2 or higher bleeding event

    Time frame: 7 days

    Grade 2 or higher bleeding event, depending on platelet shelf life.

Study contacts

Contact information is provided by the study sponsor or research team.

Charline Vauchy, PhD.

CONTACT

[email protected]

+33381218875

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ECLAT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 3, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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