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

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Von Willebrand Diseases; Major Constitutional Thrombopathy; Patient on Antiplatelet Drugs

Treatments: Biological: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT03773159

De MAISTRE ANR 2017

Details and patient eligibility

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

200 participants in 2 patient groups

Patients

Description:

Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs

Treatment:

Biological: Blood sampling

Controls

Description:

Blood donors at the French blood establishment in Burgundy Franche-Comté

Treatment:

Biological: Blood sampling