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Platelet Dysfunction in Blood Donors

Prevalence of Platelet Dysfunction Inblood With a Bleeding History

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03599219
Acronym
DysPlaq
Enrollment
1500
Registered
2018-07-26
Start date
2017-07-10
Completion date
2019-06-07
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Dysfunction in Blood Donors

Keywords

platelets, bleeding

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.

Detailed 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

Interventions

BIOLOGICALsample

confirmation of platelet dysfunction

Sponsors

University of Marseille
CollaboratorOTHER
Etablissement Français du Sang
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

prospective case control

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Platelet functionsfirst visit 1 weekQuantification of surface platelet proteins by flow cytometry

Secondary

MeasureTime frameDescription
Exploration of Coagulationfirst visit 1 weekVon Willebrand factor quantification

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026