Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT03773159

Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

Led by Centre Hospitalier Universitaire Dijon · Updated on 2026-04-02

200

Participants Needed

2

Research Sites

469 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions. An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy). The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions. Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).

CONDITIONS

Official Title

Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Person who has given oral consent
  • Adult
  • Blood donor at EFS Bourgogne Franche-Comté
  • Patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
  • Patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital
Not Eligible

You will not qualify if you...

  • Not affiliated to or not a beneficiary of national health insurance
  • Subject to court-ordered protection (curatorship, guardianship)
  • Pregnant, parturient, or breastfeeding woman
  • Unable to consent
  • On anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

CHU de Besançon

Besançon, France

Actively Recruiting

2

CHU Dijon Bourgogne

Dijon, France

Actively Recruiting

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Research Team

E

Emmanuel De Maistre

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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