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

Von Willebrand Diseases Major Constitutional Thrombopathy Patient on Antiplatelet Drugs

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

Plain Language Summary

Simplified for easier understanding

This French study is developing and validating a new laboratory device that measures how well platelets — the blood cells responsible for clotting — function under conditions that mimic blood flow in real vessels. The device is being tested in healthy blood donors, patients with known platelet disorders (like von Willebrand disease), and patients currently taking antiplatelet medications. The goal is a better diagnostic tool for bleeding disorders. You may be eligible if: - You are an adult who has given consent - You are a blood donor at EFS Bourgogne Franche-Comté, OR - You are a patient with von Willebrand disease or constitutional thrombopathy (platelet disorder) followed at a specialist center, OR - You are a patient on antiplatelet medication being followed for thrombosis You may NOT be eligible if: - You are not enrolled in or a beneficiary of the national health insurance system - You are under legal protection (curatorship or guardianship) - You are pregnant, breastfeeding, or in labor - You are unable to provide consent - You are taking anti-inflammatory medications or SSRI antidepressants (which affect platelet function) Talk to your hematologist or specialist about whether your platelet disorder or antiplatelet therapy qualifies you for this blood flow testing study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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