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Platelet Dysfunction in Blood Donors (DysPlaq)

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ClinicalTrials.gov Identifier: NCT03599219
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
University of Marseille
Information provided by (Responsible Party):
Etablissement Français du Sang

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.


Condition or disease Intervention/treatment Phase
Platelet Dysfunction in Blood Donors Biological: sample Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective case control
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Platelet Dysfunction Inblood With a Bleeding History
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : June 7, 2019
Estimated Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: questionnary to obtain an hemorrhagic score

control
donors with an hemorrhagic score <2.
Biological: sample
confirmation of platelet dysfunction
Other Name: questionnary to obtain an hemorrhagic score




Primary Outcome Measures :
  1. Platelet functions [ Time Frame: first visit 1 week ]
    Quantification of surface platelet proteins by flow cytometry


Secondary Outcome Measures :
  1. Exploration of Coagulation [ Time Frame: first visit 1 week ]
    Von Willebrand factor quantification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599219


Contacts
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Contact: Chiaroni Jacques, Professor + 33 (0) 491189557 jacques.chiaroni@efs.sante.fr
Contact: Alessi Marie-Christine, Professor +33 (0) 4 91 32 45 06 marie-christine.alessi@univ-amu.fr

Locations
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France
Maison Du Don Recruiting
Marseille, France, 13005
Contact: Christophe Picard, Dr    +33 (0) 491189596    christophe.picard@efs.sante.fr   
Sponsors and Collaborators
Etablissement Français du Sang
University of Marseille
Investigators
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Principal Investigator: Picard Christophe, Dr Etablissement francais du sang

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Responsible Party: Etablissement Français du Sang
ClinicalTrials.gov Identifier: NCT03599219     History of Changes
Other Study ID Numbers: APR2016-27
2016-A00117-44 ( Registry Identifier: RCB )
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Etablissement Français du Sang:
platelets
bleeding
Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases