Platelet Dysfunction in Blood Donors

NCT03599219 | Completed

• 2 other identifiers: APR2016-272016-A00117-44
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates. In recent decades, considerable progress has been made in understanding qualitative platelet disorders. In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.

Conditions

Platelet Dysfunction in Blood Donors

Keywords

platelets; bleeding

Outcome Measures

Primary Outcomes (1)

• Platelet functions

  Quantification of surface platelet proteins by flow cytometry

  first visit 1 week

Secondary Outcomes (1)

• Exploration of Coagulation

  first visit 1 week

Study Arms (2)

case

OTHER

donors with an hemorrhagic score \>2 and / or hematoma (more than 4 cm) that occurred during blood donation

Biological: sample

control

OTHER

donors with an hemorrhagic score \<2.

Biological: sample

Interventions

sample BIOLOGICAL

confirmation of platelet dysfunction

Also known as: questionnary to obtain an hemorrhagic score

case; control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Any male or female volunteer eligible for the blood donation

You may not qualify if:

• Subject with contraindications to blood donation:
• weight \<50 kg;
• severe fatigue,
• anemia,
• insulin-dependent diabetes;
• subject treated for epileptic seizures or having followed a treatment whose arrest is less than 14 days old.
• active pregnancy or childbirth less than 6 months old.
• viral disease (eg influenza, gastroenteritis ...) active less than two weeks after the end of symptoms.
• waiting period not respected after certain acts of daily life according to the regulatory criteria set by the EFS
• HIV infection, hepatitis B, hepatitis C

Sponsors & Collaborators

• Etablissement Français du Sang: lead
• University of Marseille: collaborator

Study Sites (1)

Maison Du Don

Marseille, 13005, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Picard Christophe, Dr

  Etablissement francais du sang

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective case control

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: July 26, 2018
• Study Start: July 10, 2017
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

FR (1)