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

February 16, 2024 updated by: Centre Hospitalier Universitaire Dijon

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs
Biological: Blood sampling
4 citrated/PPACK tubes and 1 EDTA tube maximum
Controls
Blood donors at the French blood establishment in Burgundy Franche-Comté
Biological: Blood sampling
4 citrated/PPACK tubes and 1 EDTA tube maximum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Repeatability and reproducibility of the result in controls
Time Frame: Baseline
Baseline
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • De MAISTRE ANR 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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