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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00660946
First received: April 11, 2008
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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


Condition
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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion Criteria:

  • On warfarin for less than 1 month.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00660946

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

Additional Information:
No publications provided by Mayo Clinic

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

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

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014