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

Recruitingn/aAges 18 Years - anyAllCentre Hospitalier Universitaire Dijon
NCT03773159 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ci

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📋 Eligibility rules (as published)
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)
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What it tests

  • Blood sampling
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Where

2 sites
CHU de Besançon
Besançon, France
CHU Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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