Device to evaluate blood clotting under real flow conditions
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
This study is testing a new device that simulates blood flow to see if it can better identify bleeding risks in people with von Willebrand disease or those on blood-thinning medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 2 sites (Besançon and 1 other locations) |
| Trial ID | NCT03773159 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a device that assesses primary hemostasis, which is the body's initial response to stop bleeding, under conditions that mimic actual blood flow. Current tests focus on individual components like platelets or von Willebrand factor, but do not account for the complexities of whole blood and flow dynamics. By using a device that simulates a blood vessel, the study seeks to better identify bleeding risks in patients with von Willebrand disease, major constitutional thrombopathy, or those on antiplatelet therapy. Participants will provide blood samples as part of routine testing to evaluate the device's performance.
Who should consider this trial
Good fit: Ideal candidates include adults with von Willebrand disease, major constitutional thrombopathy, or those on antiplatelet drugs who are receiving care at specific hospitals.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could lead to more accurate assessments of bleeding risk in patients, improving clinical decision-making and patient outcomes.
How similar studies have performed: While there are existing tests for hemostasis, this approach is novel as it aims to replicate physiological conditions more accurately than previous methods.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Besançon and 1 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- CHU Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Emmanuel De Maistre
- Email: emmanuel.demaistre@chu-dijon.fr
- Phone: 03 81 61 56 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.