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

Recruiting

• Conditions: Von Willebrand Diseases; Major Constitutional Thrombopathy; Patient on Antiplatelet Drugs
• Interventions: Biological: Blood sampling

• Registration Number: NCT03773159
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Study Start: 2019-05-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Blood sampling	Blood donors at the French blood establishment in Burgundy Franche-Comté
Patients	Blood sampling	Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs

Primary Outcome Measures

Name	Time	Method
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy	Baseline
Repeatability and reproducibility of the result in controls	Baseline

Trial Locations

Locations (2)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

CHU de Besançon; 🇫🇷 Besançon, France