Anticoagulation in Dialysis PatientsNCT00660946
Comparison of Point of Care to Lab INR in Dialysis Patients on Warfarin
An observational study of Anticoagulation in Dialysis Patients, run by Mayo Clinic.
Trial summary
To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anticoagulation in Dialysis Patients
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Dec 2005
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis patients who undergo INR testing in the management their chronic warfarin therapy.
Who may be able to join
- Chronic dialysis patients on chronic warfarin anticoagulation.
Who cannot join
- On warfarin for less than 1 month.
About this study
Official title: Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin
To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.
Read the detailed description
37 chronic hemodialysis patients being anticoagulated with warfarin require INR monitoring routinely.
- Conditions
- Anticoagulation in Dialysis Patients
- Keywords
- anticoagulation in dialysis patients, chronic anticoagulation, warfarin, hemodialysis, INR, Point of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 37 dialysis patients | 37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether Point of Care INR testing would be suitable in the management of dialysis patients on chronic warfarin therapy
Measured: 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
Measured: Not an intervention study, but observational in the cohort (statistics completed 1.5 yrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJun 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticoagulation in Dialysis PatientsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Robert W. Hoel, Pharm D, Principal investigator, Mayo Clinic Rochester, Mn USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660946
- Sponsor's protocol ID
- 618-05
- Status last verified
- Mar 2023
- First submitted
- 11 Apr 2008
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoel RW, Albright RC, Beyer LK, Santrach PJ, Magtibay DL, Everson SL, McBane RD. Correlation of point-of-care International Normalized Ratio to laboratory International Normalized Ratio in hemodialysis patients taking warfarin. Clin J Am Soc Nephrol. 2009 Jan;4(1):99-104. doi: 10.2215/CJN.03360708. Epub 2008 Nov 5.
PubMed 18987294