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Completed

NCT Number: NCT03599219

Platelet Dysfunction in Blood Donors

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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Key information

Conditions

Platelet Dysfunction in Blood Donors Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maison Du Don

Marseille, 13005, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sample

Biological

confirmation of platelet dysfunction

Other names: questionnary to obtain an hemorrhagic score

Primary outcomes

  1. Platelet functions

    Time frame: first visit 1 week

    Quantification of surface platelet proteins by flow cytometry

Secondary outcomes

  1. Exploration of Coagulation

    Time frame: first visit 1 week

    Von Willebrand factor quantification

Sponsors and collaborators

Lead sponsor

Etablissement Français du Sang

Other

Collaborators

  • University of Marseille

Registry information

Official study title

Prevalence of Platelet Dysfunction Inblood With a Bleeding History

Acronym: DysPlaq

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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