Validation of a Portable Medical Device for Diagnostic in Vitro (HEMOPTIC)

Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters

This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

This device was created as an alternative to blood sample, that have to be done in a medical laboratory.

The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer; Patients Under Vitamin K Antagonist (VKA)
• Intervention / Treatment: Device: HEMOPTIC

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Tronche, France, 38700
    • UniversityHospitalGrenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria of healthy volunteers:

• Man or woman between 18 and 70 years
• Body Mass Index >18 and <29
• Absence of any acute pathology in the month preceding the study
• To be affiliated or beneficiary of social security

Exclusion Criteria of healthy volunteers:

• Pregnant, partutient or breastfeeding woman
• Patient with Raynaud's syndrome
• Person deprived of liberty by legal or administrative decision, person to a legal protection order
• Deferral periods for other clinical studies
• Annual threshold compensation attain for biomedical search participations

Inclusion Criteria of patients:

• Man or woman between 18 and 80 years
• Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
• Absence of any acute pathology in the month preceding the study
• To be affiliated or beneficiary of social security

Exclusion Criteria of healthy patients:

• Pregnant, partutient or breastfeeding woman
• Patient with Raynaud's syndrome
• Person deprived of liberty by legal or administrative decision, person to a legal protection order
• Deferral periods for other clinical studies
• Annual threshold compensation attain for biomedical search participations

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers and patients under Vitamin K antagonist	Device: HEMOPTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Normalized Ratio measurement: comparison to the standard reference.	V2

Secondary Outcome Measures

Outcome Measure	Time Frame
International Normalized Ratio measurement: repeatability	V2
International Normalized Ratio measurement:reproductibility	V2

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Luc Cracowski, Professor, Grenoble Hospital University

Publications and helpful links

General Publications

• Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617. Erratum In: N Engl J Med. 2011 Jan 6;364(1):93.
• Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367(9508):404-11. doi: 10.1016/S0140-6736(06)68139-7.
• Faivre M, Peltie P, Planat-Chretien A, Cosnier ML, Cubizolles M, Nougier C, Negrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813.
• McBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062.
• Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Medical device; Vitamin K antagonist; Hemoptic; Diagnostic in vitro
• Other Study ID Numbers: 38RC14.008