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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03773159
Acronym
INDONESIA
Enrollment
200
Registered
2018-12-12
Start date
2019-05-06
Completion date
2028-05-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

BIOLOGICALBlood sampling

4 citrated/PPACK tubes and 1 EDTA tube maximum

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Repeatability and reproducibility of the result in controlsBaseline
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathyBaseline

Countries

France

Contacts

CONTACTEmmanuel De Maistre
emmanuel.demaistre@chu-dijon.fr03 81 61 56 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026