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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 : Recruiting
First Posted : December 12, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date December 10, 2018
First Posted Date December 12, 2018
Last Update Posted Date May 14, 2019
Actual Study Start Date May 6, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2018)
  • Repeatability and reproducibility of the result in controls [ Time Frame: Baseline ]
  • Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy [ Time Frame: Baseline ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03773159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Official Title Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs
Condition
  • Von Willebrand Diseases
  • Major Constitutional Thrombopathy
  • Patient on Antiplatelet Drugs
Intervention Biological: Blood sampling
4 citrated/PPACK tubes and 1 EDTA tube maximum
Study Groups/Cohorts
  • Patients
    Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs
    Intervention: Biological: Blood sampling
  • Controls
    Blood donors at the French blood establishment in Burgundy Franche-Comté
    Intervention: Biological: Blood sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Emmanuel De Maistre 03 81 61 56 15 emmanuel.demaistre@chu-dijon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03773159
Other Study ID Numbers De MAISTRE ANR 2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date December 2018