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Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

NCT00703963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-08-28

Study results available
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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.

Conditions

  • Management of Anticoagulation

Interventions

DEVICE

INRatio monitor by Hemosense

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.

OTHER

Usual Care

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.

Sponsors & Collaborators

  • LivaNova

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Hartzell V Schaff, M.D. CS · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703963 on ClinicalTrials.gov