Mechanical Aortic and/or Mitral Valve Replacement Operation
Conditions
Keywords
anticoagulation, fluindione, patient self-testing, coaguchek, inratio, Post operative antivitamin K therapy
Brief summary
The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.
Detailed description
This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement. Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).
Interventions
OTHERINR self-testing program
Sponsors
Abbott Medical Devices
Roche Diagnostics GmbH
HemoSense
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* adults * patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization * oral anticoagulant treatment * patients with social security cover * written informed consent signed by both patient and investigator * able to be followed up during 12 months
Exclusion criteria
* refusal of participation in the study * Participation in another clinical study * Patient is pregnant or nursing * Life expectancy less than three months * Contra-indication of to an A.V.K treatment * Difficult comprehension of the French language * Patients unable to master the self-monitoring procedures * Individuals under judicial control or enquiry * Patients on dialysis Patients with incomplete understanding of instructions * Blind patients and those unable to read
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemorrhagic events and thromboembolic events | after mechanical heart valve replacement |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of laboratory INR and device INR control | after mechanical heart valve replacement |
Outcome results
None listed