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Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

NCT04136379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2022-11-03

No results posted yet for this study

Summary

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.

Conditions

  • Congenital Heart Disease
  • Congenital Heart Defect
  • Adult Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

INR monitoring using a CoaguChek POC device

INR monitoring using a CoaguChek POC device

Sponsors & Collaborators

  • Belfast Health and Social Care Trust

    collaborator OTHER

  • University of Ulster

    lead OTHER

Principal Investigators

  • Ciara Hughes, PhD · Ulster University

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT04136379 on ClinicalTrials.gov