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

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ClinicalTrials.gov Identifier: NCT03773159
Recruitment Status : Not yet recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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
Von Willebrand Diseases Major Constitutional Thrombopathy Patient on Antiplatelet Drugs Biological: Blood sampling

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Repeatability and reproducibility of the result in controls [ Time Frame: Baseline ]
  2. Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773159


Contacts
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Contact: Emmanuel De Maistre 03 81 61 56 15 emmanuel.demaistre@chu-dijon.fr

Locations
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France
CHU de Besançon Not yet recruiting
Besançon, France
Contact: Guillaume MOUREY    03 81 61 56 15    guillaume.mourey@efs.sante.fr   
CHU Dijon Bourgogne Not yet recruiting
Dijon, France
Contact: Emmanuel De Maistre    03 80 29 32 57    emmanuel.demaistre@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03773159     History of Changes
Other Study ID Numbers: De MAISTRE ANR 2017
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hemostatics
Coagulants