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

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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Key information

Conditions

Von Willebrand Diseases Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Major Constitutional Thrombopathy Patient on Antiplatelet Drugs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling

Biological

4 citrated/PPACK tubes and 1 EDTA tube maximum

Primary outcomes

Repeatability and reproducibility of the result in controls

Time frame: Baseline
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy

Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel De Maistre

CONTACT

[email protected]

03 81 61 56 15

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: INDONESIA

Important dates

Study start: 2019
Primary completion: 2028
Study completion: 2028
First posted: Dec 12, 2018
Registry last updated: Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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