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Comparison of Point of Care to Lab INR in Dialysis Patients on Warfarin

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00660946
Collaborator
(none)
37
Enrollment
6
Duration (Months)

Study Details

Study Description

Brief Summary

To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    37 chronic hemodialysis patients being anticoagulated with warfarin require INR monitoring routinely.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin
    Study Start Date :
    Jun 1, 2005
    Actual Primary Completion Date :
    Dec 1, 2005
    Actual Study Completion Date :
    Dec 1, 2005

    Arms and Interventions

    Arm Intervention/Treatment
    37 dialysis patients

    37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management.

    Outcome Measures

    Primary Outcome Measures

    1. To determine whether Point of Care INR testing would be suitable in the management of dialysis patients on chronic warfarin therapy [Not an intervention study, but observational in this cohort]

    Secondary Outcome Measures

    1. Determine whether Point of Care INR devices maintain test accuracy in dialysis patients who are temporarily anemic (HCT <32%) according to their CBC [Not an intervention study, but observational in the cohort (statistics completed 1.5 yrs)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic dialysis patients on chronic warfarin anticoagulation.
    Exclusion Criteria:
    • On warfarin for less than 1 month.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Robert W. Hoel, Pharm D, Mayo Clinic Rochester, Mn USA

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00660946
    Other Study ID Numbers:
    • 618-05
    First Posted:
    Apr 17, 2008
    Last Update Posted:
    Apr 17, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    anticoagulation in dialysis patients
    chronic anticoagulation
    warfarin
    hemodialysis
    INR
    Point of Care

    Study Results

    No Results Posted as of Apr 17, 2008