RecruitingNCT03773159

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


Sponsor

Centre Hospitalier Universitaire Dijon

Enrollment

200 participants

Start Date

May 6, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • person who has given oral consent
  • adult
  • blood donor at EFS Bourgogne Franche-Comté
  • or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
  • or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital

Exclusion Criteria5

  • a person who is not affiliated to or not a beneficiary of national health insurance
  • person subject to court-ordered protection (curatorship, guardianship)
  • pregnant, parturient or breastfeeding woman
  • a person who is unable to consent
  • person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALBlood sampling

4 citrated/PPACK tubes and 1 EDTA tube maximum


Locations(2)

CHU de Besançon

Besançon, France

CHU Dijon Bourgogne

Dijon, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03773159


Related Trials