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

Von Willebrand Diseases Clinical Trial

— INDONESIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773159
• Other study ID #: De MAISTRE ANR 2017
• Status: Recruiting
• Start date: May 6, 2019
• Est. completion date: May 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Emmanuel De Maistre
• Phone: 03 81 61 56 15
• Email: emmanuel.demaistre[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Biological:
• Blood sampling
4 citrated/PPACK tubes and 1 EDTA tube maximum

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeatability and reproducibility of the result in controls		Baseline
Primary	Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy		Baseline