Platelet Dysfunction in Blood Donors

Platelet Dysfunction in Blood Donors Clinical Trial

— DysPlaq  

Official title:

Prevalence of Platelet Dysfunction Inblood With a Bleeding History

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599219
• Other study ID #: APR2016-27
• Secondary ID: 2016-A00117-44
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: June 7, 2019

Study information

• Verified date: January 2024
• Source: Etablissement Français du Sang
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary objective specify the prevalence of qualitative platelet disorders in blood donors with i) a clinical history of bleeding diathesis collected through a standardized and validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood donation.

Secondary objectives to obtain the prevalence of other defects of hemostasis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Any male or female volunteer eligible for the blood donation

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Blood Platelet Disorders
• Platelet Dysfunction in Blood Donors

Intervention

Biological:
• sample
confirmation of platelet dysfunction

Locations

Country	Name	City	State
France	Maison Du Don	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Etablissement Français du Sang	University of Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet functions	Quantification of surface platelet proteins by flow cytometry	first visit 1 week
Secondary	Exploration of Coagulation	Von Willebrand factor quantification	first visit 1 week