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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03773159

Collaborator

(none)

200

Enrollment

Locations

59.9

Anticipated Duration (Months)

100

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Von Willebrand Diseases Major Constitutional Thrombopathy Patient on Antiplatelet Drugs	Biological: Blood sampling

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 6, 2019

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Repeatability and reproducibility of the result in controls [Baseline]
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besançon		France
2	CHU Dijon Bourgogne	Dijon		France

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT03773159

Other Study ID Numbers:

De MAISTRE ANR 2017

First Posted:

Dec 12, 2018

Last Update Posted:

May 3, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Von Willebrand Diseases

Study Results

No Results Posted as of May 3, 2022