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

March 20, 2023 updated by: Mayo Clinic

Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dialysis patients who undergo INR testing in the management their chronic warfarin therapy.

Description

Inclusion Criteria:

  • Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion Criteria:

  • On warfarin for less than 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
37 dialysis patients
37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether Point of Care INR testing would be suitable in the management of dialysis patients on chronic warfarin therapy
Time Frame: Not an intervention study, but observational in this cohort
Not an intervention study, but observational in this cohort

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

April 11, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 618-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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