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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin
- ClinicalTrials.gov ID
- NCT00660946
- Acronym / sponsor ID
- 618-05
- Conditions
- Anticoagulation in Dialysis Patients
- Keywords
- anticoagulation in dialysis patients, chronic anticoagulation, warfarin, hemodialysis, INR, Point of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.
Detailed description
37 chronic hemodialysis patients being anticoagulated with warfarin require INR monitoring routinely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 37 dialysis patients | – | –37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis patients who undergo INR testing in the management their chronic warfarin therapy.
Key inclusion criteria (1 listed)
- Chronic dialysis patients on chronic warfarin anticoagulation.
Key exclusion criteria (1 listed)
- On warfarin for less than 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 18987294Hoel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W. Hoel, Pharm D principal investigator
Mayo Clinic Rochester, Mn USA
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation in Dialysis Patients, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.