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Platelet Dysfunction in Blood Donors (DysPlaq)

Primary Purpose

Platelet Dysfunction in Blood Donors

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sample
Sponsored by
Etablissement Français du Sang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Platelet Dysfunction in Blood Donors focused on measuring platelets, bleeding

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Maison Du DonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

case

control

Arm Description

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

donors with an hemorrhagic score <2.

Outcomes

Primary Outcome Measures

Platelet functions
Quantification of surface platelet proteins by flow cytometry

Secondary Outcome Measures

Exploration of Coagulation
Von Willebrand factor quantification

Full Information

First Posted
February 27, 2018
Last Updated
April 26, 2019
Sponsor
Etablissement Français du Sang
Collaborators
University of Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03599219
Brief Title
Platelet Dysfunction in Blood Donors
Acronym
DysPlaq
Official Title
Prevalence of Platelet Dysfunction Inblood With a Bleeding History
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
June 7, 2019 (Anticipated)
Study Completion Date
June 7, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Etablissement Français du Sang
Collaborators
University of Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Dysfunction in Blood Donors
Keywords
platelets, bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective case control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
case
Arm Type
Other
Arm Description
donors with an hemorrhagic score >2 and / or hematoma (more than 4 cm) that occurred during blood donation
Arm Title
control
Arm Type
Other
Arm Description
donors with an hemorrhagic score <2.
Intervention Type
Biological
Intervention Name(s)
sample
Other Intervention Name(s)
questionnary to obtain an hemorrhagic score
Intervention Description
confirmation of platelet dysfunction
Primary Outcome Measure Information:
Title
Platelet functions
Description
Quantification of surface platelet proteins by flow cytometry
Time Frame
first visit 1 week
Secondary Outcome Measure Information:
Title
Exploration of Coagulation
Description
Von Willebrand factor quantification
Time Frame
first visit 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiaroni Jacques, Professor
Phone
+ 33 (0) 491189557
Email
jacques.chiaroni@efs.sante.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Alessi Marie-Christine, Professor
Phone
+33 (0) 4 91 32 45 06
Email
marie-christine.alessi@univ-amu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Picard Christophe, Dr
Organizational Affiliation
Etablissement francais du sang
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maison Du Don
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Picard, Dr
Phone
+33 (0) 491189596
Email
christophe.picard@efs.sante.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Platelet Dysfunction in Blood Donors

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