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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-06

Study Completion Date

2026-05-31

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).

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Detailed Description

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Conditions

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Von Willebrand Diseases Major Constitutional Thrombopathy Patient on Antiplatelet Drugs

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs

Blood sampling

Intervention Type BIOLOGICAL

4 citrated/PPACK tubes and 1 EDTA tube maximum

Controls

Blood donors at the French blood establishment in Burgundy Franche-Comté

Blood sampling

Intervention Type BIOLOGICAL

4 citrated/PPACK tubes and 1 EDTA tube maximum

Interventions

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Blood sampling

4 citrated/PPACK tubes and 1 EDTA tube maximum

Intervention Type BIOLOGICAL

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes