At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
In Brief
A clinical study evaluating INRatio monitor by Hemosense and Usual Care for Management of Anticoagulation. Completed, enrolled 200 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip. The test strip is then inserted into the INRatio point-of-care self-testing coagulometer. After approximately 2 minutes of analysis, the INR value will be presented on the meter's display.
Usual care is defined as that care currently received by patients into whom mechanical heart valves are placed. Typically, these patients undergo frequent checks of their INR level until the therapeutic range is achieved. Then periodic INR levels are drawn at the discretion of the managing physician.