Platelet Dysfunction in Blood Donors (DysPlaq)

January 30, 2024 updated by: Etablissement Français du Sang

Prevalence of Platelet Dysfunction Inblood With a Bleeding History

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13005
        • Maison Du Don

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: case
donors with an hemorrhagic score >2 and / or hematoma (more than 4 cm) that occurred during blood donation
Biological: sample
confirmation of platelet dysfunction
Other Names:
  • questionnary to obtain an hemorrhagic score
Other: control
donors with an hemorrhagic score <2.
Biological: sample
confirmation of platelet dysfunction
Other Names:
  • questionnary to obtain an hemorrhagic score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet functions
Time Frame: first visit 1 week
Quantification of surface platelet proteins by flow cytometry
first visit 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploration of Coagulation
Time Frame: first visit 1 week
Von Willebrand factor quantification
first visit 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Collaborators

University of Marseille

Investigators

  • Principal Investigator: Picard Christophe, Dr, Etablissement francais du sang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2017

Primary Completion (Actual)

June 7, 2019

Study Completion (Actual)

June 7, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

July 23, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR2016-27
  • 2016-A00117-44 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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