Clinical Efficacy of Platelet Transfusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

343 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-17

Study Completion Date

2028-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies

NCT02885038

Lymphoma Multiple Myeloma Lymphocytic Leukemia +1 more

COMPLETED

Retrospective Descriptive Study of Platelet Transfusion in Patients With Palliative Hematologic Malignancies at the University Hospital of Besançon

NCT03814486

Platelet Transfusion Palliative Care

COMPLETED

Injection of ex Vivo Amplified G-CSF Mobilised Autologous Peripheral Blood Stem Cell Transplantation

NCT00461955

Multiple Myeloma

COMPLETED PHASE2

Home Transfusion for HEME

NCT05509439

Hematologic Malignancy

COMPLETED NA

Effects of Blood Transfusion in Healthy Volunteers

NCT01226498

Blood Transfusion, Autologous

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombocytopaenia Haematological Malignancies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Self-assessment of bleeding events

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No