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

NCT03773159 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-02

No results posted yet for this study

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

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

Interventions

BIOLOGICAL

Blood sampling

4 citrated/PPACK tubes and 1 EDTA tube maximum

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Dijon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03773159 on ClinicalTrials.gov