N/A
N=200
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care
Management of Anticoagulation
Bottom Line
View on ClinicalTrials.gov: NCT00703963 ↗Enrolled (actual)
200
Serious AEs
6.2%
Results posted
Aug 2014
Primary outcome: Primary: Mean Percentage of Time in Therapeutic Range — 48; 53 percentage of time — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INRatio monitor by Hemosense (Device); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percentage of Time in Therapeutic Range |
48; 53 | 0.20 |
| SECONDARY Mean Percentage of INR Tests Within the Therapeutic Range |
45; 52 | 0.05 |
| SECONDARY Mean Number of INR Tests Performed |
10; 14 | <0.001 sig |
Summary
Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.
The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.
Eligibility Criteria
Inclusion Criteria
- Patients that received a mechanical valve while in our hospital
- Age > 18 years
Exclusion Criteria
- Pregnant or lactating women
- Patients that have genetic clotting disorders such as Factor 5
- Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
Data sourced from ClinicalTrials.gov (NCT00703963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.