Platelet Dysfunction in Blood Donors

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2019-06-07

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Platelet Dysfunction in Blood Donors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

prospective case control

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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case

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

Group Type OTHER

sample

Intervention Type BIOLOGICAL

confirmation of platelet dysfunction

control

donors with an hemorrhagic score \<2.

Group Type OTHER

sample

Intervention Type BIOLOGICAL

confirmation of platelet dysfunction

Interventions

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sample

confirmation of platelet dysfunction

Intervention Type BIOLOGICAL

Other Intervention Names

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questionnary to obtain an hemorrhagic score

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes