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

Study Overview
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Brief Summary
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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).

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

Conditions
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Von Willebrand Diseases, Major Constitutional Thrombopathy, Patient on Antiplatelet Drugs

Intervention / Treatment
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* Biological: Blood sampling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs | Biological: Blood sampling<br>* 4 citrated/PPACK tubes and 1 EDTA tube maximum<br>|
| Controls<br>Blood donors at the French blood establishment in Burgundy Franche-Comté | Biological: Blood sampling<br>* 4 citrated/PPACK tubes and 1 EDTA tube maximum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatability and reproducibility of the result in controls |  | Baseline | 
| Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy |  | Baseline |