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

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ClinicalTrials.gov Identifier: NCT00660946
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Sponsor:
Information provided by:
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.

Condition or disease
Anticoagulation in Dialysis Patients

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

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 : June 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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



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 [ Time Frame: 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 [ Time Frame: Not an intervention study, but observational in the cohort (statistics completed 1.5 yrs) ]


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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.
Criteria

Inclusion Criteria:

  • Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion Criteria:

  • On warfarin for less than 1 month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660946


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

Additional Information:
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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

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

Additional relevant MeSH terms:
Warfarin
Anticoagulants