Clinical Efficacy of Platelet Transfusion

NCT06805097 | Recruiting

• 1 other identifier: 2025/934
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombocytopaenia; Haematological Malignancies

Keywords

platelet concentrate; transfusion; haemorrhage

Outcome Measures

Primary Outcomes (1)

• Grade 2 or higher bleeding event

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

  7 days

Study Arms (1)

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

Interventions

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.

Patients with severe thrombocytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, 25000, France

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia; Hemorrhage

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charline Vauchy, PhD.

CONTACT

+33381218875; cvauchy@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

FR (1)