Clinical trial NCT02843958: Validation of a Portable Medical Device for Diagnostic in Vitro
Official title: Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Patients Under Vitamin K Antagonist (VKA)
Keywords: Medical device
Hemoptic
Vitamin K antagonist
Diagnostic in vitro
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: International Normalized Ratio measurement: comparison to the standard reference.
timeFrame: V2
Secondary outcomes:
measure: International Normalized Ratio measurement: repeatability
timeFrame: V2
measure: International Normalized Ratio measurement:reproductibility
timeFrame: V2
Other outcomes:
Locations:
city: La Tronche
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: Grenoble Hospital University
name: Jean-Luc Cracowski, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: McBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062.
citation: Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.