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OpenTrials
Completed

NCT Number: NCT00660946

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

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

Completed

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic dialysis patients on chronic warfarin anticoagulation.

Exclusion criteria

  • On warfarin for less than 1 month.

Treatment and study plan

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Apr 17, 2008
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.