CoagulationECLIPSE 03NCT00933738
Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)
An observational study of Coagulation, run by Abbott RDx Cardiometabolic at 12 sites in United States.
Trial summary
This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation
- How many people
- 150 participants
- Where
- 12 sitesUnited States
- Study dates
- Dec 2009to Mar 2011
- 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 undergoing heparin bridging onto OAT with warfarin.
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.
- Receiving warfarin/heparin bridge therapy.
- Therapy with both warfarin and one of the heparins listed below must have been initiated for at least 12 hours before the first study specimens are obtained.
- UH (last known aPTT prior to enrollment (if available†) must confirm heparin has been administered)
- Dalteparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered)
- Enoxaparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered) † If a pre-study aPTT or anti-factor Xa is not available, subsequent testing of the study phlebotomy or a phlebotomy as a part of routine medical care taken before or during the time of the study phlebotomy must confirm the presence of heparin (unfractionated or low molecular weight) in order for that data point to be included in the analysis.
Who cannot join
- Known or suspected hematocrit less than 25 or greater than 55%;
- Auto-immune disorders known to interfere with INR measurements, such as lupus or anti-phospholipid syndrome (APS)
- Already participated in this specific study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of New Mexico
Albuquerque, New Mexico
University of Colorado-Denver
Aurora, Colorado, 80045
New York Methodist Hospital
Brooklyn, New York, 11215
Henry Ford Hospital
Detroit, Michigan, 48202
Emergency Medicine Research Group
Lansing, Michigan, 48910
Loma Linda VA
Loma Linda, California
International Heart Institute of Montana
Missoula, Montana
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan
John T Mather Memorial Hospital
Port Jefferson, New York, 11777
Swedish Medical Center
Seattle, Washington
Northwest Heart Center
Tomball, Texas
Wenatchee Valley Medical Center
Wenatchee, Washington
About this study
This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.
- Conditions
- Coagulation
- Keywords
- Patients needing OAT (Oral Anticoagulation Therapy)
- Medical subject headings
- Thrombosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott RDx Cardiometabolic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933738
- Sponsor's protocol ID
- BSTE-0120.a
- Acronym
- ECLIPSE 03
- Status last verified
- Jun 2011
- First submitted
- 3 Jul 2009
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)
- ClinicalTrials.gov ID
- NCT00933738
- Acronym / sponsor ID
- ECLIPSE 03 / BSTE-0120.a
- Conditions
- Coagulation
- Keywords
- Patients needing OAT (Oral Anticoagulation Therapy)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Abbott RDx CardiometabolicUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Jul 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 heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heparin bridging onto OAT with warfarin.
Key inclusion criteria (7 listed)
- Adults (18 years of age or older).
- Willing and able to provide written informed consent and comply with study procedures.
- Receiving warfarin/heparin bridge therapy.
- Therapy with both warfarin and one of the heparins listed below must have been initiated for at least 12 hours before the first study specimens are obtained.
- UH (last known aPTT prior to enrollment (if available†) must confirm heparin has been administered)
Key exclusion criteria (3 listed)
- Known or suspected hematocrit less than 25 or greater than 55%;
- Auto-immune disorders known to interfere with INR measurements, such as lupus or anti-phospholipid syndrome (APS)
- Already participated in this specific 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
Not reported in the source record.
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 22 Jun 2011.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation, run by Abbott RDx Cardiometabolic at 12 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 7 inclusion and 3 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 22 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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 22 Jun 2011.