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Trial record 13 of 143 for:    warfarin AND therapeutic range

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

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ClinicalTrials.gov Identifier: NCT04136379
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
University of Ulster

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 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.

Condition or disease Intervention/treatment
Congenital Heart Disease Congenital Heart Defect Adult Congenital Heart Disease Diagnostic Test: INR monitoring using a CoaguChek POC device

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Study Type : Observational
Estimated Enrollment : 152 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Efficacy and Outcomes for Home and Standard Clinic Monitoring of INR in Patients With Congenital Heart Disease
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clinic monitoring
Patients who attend a warfarin clinic for management of their INR
Home monitoring
Patients who undertake home monitoring of their INR using a CoaguChek POC device
Diagnostic Test: INR monitoring using a CoaguChek POC device
INR monitoring using a CoaguChek POC device




Primary Outcome Measures :
  1. Time in therapeutic range (TTR) [ Time Frame: 12 months ]
    The time the patient remains within their therapeutic INR range


Secondary Outcome Measures :
  1. INR variability [ Time Frame: 12 months ]
    Absolute difference in consecutive INR results

  2. Number of Adverse events [ Time Frame: 12 months ]
    Number of thromboembolic or haemorrhage events

  3. Patient satisfaction [ Time Frame: 12 months ]
    How satisfied patients are with their current method of INR management examined using a patient satisfaction questionnaire

  4. Health related quality of life (HRQoL): Health related quality of life scores [ Time Frame: 12 months ]
    Health related quality of life scores



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who attend an ACHD clinic in the Royal Victoria Hospital, Belfast
Criteria

Home monitoring cohort

Inclusion Criteria:

  • 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 the RVH protocol for adjusting warfarin dose and are able to submit information electronically

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136379


Contacts
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Contact: Rachel L Savage 07718816193 savage-r4@ulster.ac.uk

Locations
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United Kingdom
Royal Victoria Hospital Recruiting
Belfast, United Kingdom
Contact: Rachel L Savage    07718816193    savage-r4@ulster.ac.uk   
Sponsors and Collaborators
University of Ulster
Belfast Health and Social Care Trust
Investigators
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Principal Investigator: Ciara Hughes, PhD Ulster University

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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT04136379    
Other Study ID Numbers: 18/0081
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Ulster:
Warfarin therapy
INR monitoring
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Warfarin
Anticoagulants