Pulmonary EmbolismECLIPSE-01NCT01037270
Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
An observational study of Pulmonary Embolism and Atrial Fibrillation, run by Abbott RDx Cardiometabolic at 4 sites in United States.
Trial summary
This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Atrial Fibrillation, Deep Vein Thrombosis
- How many people
- 271 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2009to Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
Who may be able to join
- Adults (18 years of age or older);
- Willing and able to provide written informed consent and comply with study procedures;
- Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.
Who cannot join
- Hematocrit less than 25 or greater than 55%;
- Lupus or antiphospholipid syndrome (APS)
- Vulnerable populations deemed inappropriate for study by the site's principal investigator.
- Already participated in this study.
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 is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
- Keywords
- Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.
- Medical subject headings
- Pulmonary Embolism, Atrial Fibrillation, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2009 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies 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
- 271 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
- NCT01037270
- Sponsor's protocol ID
- BSTE-0124
- Acronym
- ECLIPSE-01
- 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
- Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
- ClinicalTrials.gov ID
- NCT01037270
- Acronym / sponsor ID
- ECLIPSE-01 / BSTE-0124
- Keywords
- Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 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 is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
Key inclusion criteria (3 listed)
- Adults (18 years of age or older);
- Willing and able to provide written informed consent and comply with study procedures;
- Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.
Key exclusion criteria (4 listed)
- Hematocrit less than 25 or greater than 55%;
- Lupus or antiphospholipid syndrome (APS)
- Vulnerable populations deemed inappropriate for study by the site's principal investigator.
- Already participated in this study.
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
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.
Time frame: 3-6 months
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 Pulmonary Embolism and Atrial Fibrillation, 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 3 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?
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. (time frame: 3-6 months). 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.