Comparison of Point of Care to Lab INR in Dialysis Patients on Warfarin - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00660946

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

MedlinePlus related topics: Blood Thinners Dialysis Kidney Failure

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Pharmacy Services Department, Mayo Clinic ( Robert W. Hoel, Pharm D, Primary Investigator )
Study ID Numbers:	618-05
Study First Received:	April 11, 2008
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00660946
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

anticoagulation in dialysis patients
chronic anticoagulation
warfarin

hemodialysis
INR
Point of Care

Study placed in the following topic categories:

Warfarin

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009