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

Completed

• Conditions: Anticoagulation in Dialysis Patients

• Registration Number: NCT00660946
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Chronic dialysis patients on chronic warfarin anticoagulation.

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Exclusion Criteria

• On warfarin for less than 1 month.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)