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

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: April 11, 2008
Last updated: April 16, 2008
Last verified: April 2008
To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.

Anticoagulation in Dialysis Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 37
Study Start Date: June 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
37 dialysis patients
37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management.

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients who undergo INR testing in the management their chronic warfarin therapy.

Inclusion Criteria:

  • Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion Criteria:

  • On warfarin for less than 1 month.
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Please refer to this study by its identifier: NCT00660946

Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Robert W. Hoel, Pharm D Mayo Clinic Rochester, Mn USA
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert W. Hoel, Pharm D, Primary Investigator, Pharmacy Services Department, Mayo Clinic Identifier: NCT00660946     History of Changes
Other Study ID Numbers: 618-05
Study First Received: April 11, 2008
Last Updated: April 16, 2008

Keywords provided by Mayo Clinic:
anticoagulation in dialysis patients
chronic anticoagulation
Point of Care

Additional relevant MeSH terms:
Anticoagulants processed this record on August 18, 2017