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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Blood sampling

Treatment groups

200 Participants
are divided into 2 treatment groups