NCT03773159 Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
| NCT ID | NCT03773159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Von Willebrand Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-05-06 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-05-06 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03773159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Von Willebrand Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03773159 currently recruiting?
Yes, NCT03773159 is actively recruiting participants. Contact the research team at emmanuel.demaistre@chu-dijon.fr for enrollment information.
Where is the NCT03773159 trial being conducted?
This trial is being conducted at Besançon, France, Dijon, France.
Who is sponsoring the NCT03773159 clinical trial?
NCT03773159 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 200 participants.