Oral AnticoagulationECLIPSE-02NCT01036646
User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
An observational study of Oral Anticoagulation, run by Abbott RDx Cardiometabolic at 4 sites in United States.
Trial summary
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Anticoagulation
- How many people
- 183 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2009to Sep 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from their primary care clinic.
Who may be able to join
- Adults (18 years of age or older);
- Ability to read and speak English;
- Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
- Target INR interval between 2.0 and 4.5
- Willing and able to provide written informed consent and comply with study procedures;
Who cannot join
- Hematocrit less than 25 or greater than 55%
- Lupus or antiphospholipid syndrome (APS)
- Already participated in this study
- A current INRatio PT Monitoring System User / Patient Self Tester
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Fox Valley Cardiology
Aurora, Illinois, 60504
Loma Linda VA Hospital
Loma Linda, California, 92357
UC Davis Healthcare System
Sacramento, California, 95817
San Diego Cardiac Center
San Diego, California, 92123
About this study
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.
- Conditions
- Oral Anticoagulation
- Keywords
- Patients on stable OAT therapy for at least 3 months.
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 |
|---|---|---|
| BSTE-0125-Original Protocol | Not described | |
| BSTE-0125.a-Amended Protocol | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral AnticoagulationStudies of the same condition, open and under way.
- 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
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036646
- Sponsor's protocol ID
- BSTE-0125
- Acronym
- ECLIPSE-02
- Status last verified
- Feb 2013
- First submitted
- 17 Dec 2009
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
- ClinicalTrials.gov ID
- NCT01036646
- Acronym / sponsor ID
- ECLIPSE-02 / BSTE-0125
- Conditions
- Oral Anticoagulation
- Keywords
- Patients on stable OAT therapy for at least 3 months.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Dec 2009 (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.
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSTE-0125-Original Protocol | – | – |
| BSTE-0125.a-Amended Protocol | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from their primary care clinic.
Key inclusion criteria (5 listed)
- Adults (18 years of age or older);
- Ability to read and speak English;
- Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
- Target INR interval between 2.0 and 4.5
- Willing and able to provide written informed consent and comply with study procedures;
Key exclusion criteria (4 listed)
- Hematocrit less than 25 or greater than 55%
- Lupus or antiphospholipid syndrome (APS)
- Already participated in this study
- A current INRatio PT Monitoring System User / Patient Self Tester
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
Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.
Time frame: 8 weeks
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 11 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Anticoagulation, run by Abbott RDx Cardiometabolic at 4 sites in United States.
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 5 inclusion and 4 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2013.