NCT03773159

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Von Willebrand Diseases
• Major Constitutional Thrombopathy
• Patient on Antiplatelet Drugs

Interventions

Type	Name	Description
BIOLOGICAL	Blood sampling	4 citrated/PPACK tubes and 1 EDTA tube maximum

Timeline

• Start date: 2019-05-06
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2018-12-12
• Last updated: 2026-04-02

Locations

2 sites across 1 country: France