Status:
COMPLETED
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Lead Sponsor:
University of Ulster
Collaborating Sponsors:
Belfast Health and Social Care Trust
Conditions:
Congenital Heart Disease
Congenital Heart Defect
Eligibility:
All Genders
14+ years
Brief 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 cereb...
Detailed Description
Aims and Objectives: The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients over 14 years of age with CHD and to determine w...
Eligibility Criteria
Inclusion
- Home monitoring cohort
- 14+ years old
- Adult Congenital Heart Disease (ACHD)
- attend a clinic in the RVH
- Able to understand, speak, read and write in English
- Patients who currently home manage their INR using a CoaguChek system and are able to submit information electronically
Exclusion
- Patients using a CoaguChek S monitor, as this is an older monitor which uses a different mechanism to measure INR compared with the newer models
- Patients who have been using a CoaguChek \<6 months.
- Patients who are cyanotic will be excluded if their haematocrit is \>55
- Patients who are pregnant will be excluded as warfarin is not prescribed during the first and third trimesters of pregnancy.
- Clinic monitoring cohort
- Inclusion Criteria:
- 14+ years, have ACHD
- Attend a clinic in the RVH
- Able to understand, speak, read and write in English
- INR managed by a warfarin clinic
- Able to submit information electronically
- Exclusion Criteria
- Patients who have been on warfarin \<6 months.
- Patients who are pregnant will be excluded as warfarin is not prescribed during the first and third trimesters of pregnancy.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04136379
Start Date
September 30 2019
End Date
October 31 2021
Last Update
November 3 2022
Active Locations (1)
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1
Royal Victoria Hospital
Belfast, United Kingdom