Validation of a Portable Medical Device for Diagnostic in Vitro
NCT ID: NCT02843958
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2013-06-30
2014-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Healthy volunteers and patients under Vitamin K antagonist
HEMOPTIC
Interventions
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HEMOPTIC
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc Cracowski, Professor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
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UniversityHospitalGrenoble
La Tronche, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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38RC14.008
Identifier Type: -
Identifier Source: org_study_id