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

NCT03773159 | Recruiting

• 1 other identifier: De MAISTRE ANR 2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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).

Conditions

Major Constitutional Thrombopathy; Patient on Antiplatelet Drugs; Von Willebrand Diseases

Outcome Measures

Primary Outcomes (2)

• Repeatability and reproducibility of the result in controls

  Baseline

• Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy

  Baseline

Study Arms (2)

Patients

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

Biological: Blood sampling

Controls

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

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

4 citrated/PPACK tubes and 1 EDTA tube maximum

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CHU de Besançon

Besançon, France

RECRUITING

CHU Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

von Willebrand Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Emmanuel De Maistre

CONTACT

03 81 61 56 15; emmanuel.demaistre@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: May 6, 2019
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

FR (2)