Clotting DisordersNCT01375725
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
An observational study of Clotting Disorders, run by Universal Biosensors Pty Ltd at 1 site in United States.
Trial summary
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clotting Disorders
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 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: Subjects currently receiving coumadin (warfarin) treatment
Who may be able to join
- Are currently taking coumadin (warfarin)
- Are aged 18 years or older
- Able and willing to provide informed consent
- Can understand (read and write) English
- Required to provide a capillary sample as part of their routine medical check
Who cannot join
- Previously participated in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Diagnostic Clinic
Batesville, Arkansas, 72501
About this study
Official title: Mobius PT-INR Accuracy Clinical Study
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.
- Conditions
- Clotting Disorders
- Medical subject headings
- Hemostatic Disorders
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 |
|---|---|---|
| Coumadin (warfarin) | Subjects currently receiving coumadin (warfarin) treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
To determine the correlation of PT/INR values between an experimental and commercial device
Measured: Five days to collect data and up to two weeks to generate correlation graph
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionSep 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 Clotting DisordersStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Biosensors Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Ward, Pharm.D, Principal investigator, Harding University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375725
- Sponsor's protocol ID
- MOB 0046
- Status last verified
- Jun 2011
- First submitted
- 15 Jun 2011
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobius PT-INR Accuracy Clinical Study
- ClinicalTrials.gov ID
- NCT01375725
- Acronym / sponsor ID
- MOB 0046
- Conditions
- Clotting Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universal Biosensors Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Jun 2011 (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.
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coumadin (warfarin) | – | –Subjects currently receiving coumadin (warfarin) treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects currently receiving coumadin (warfarin) treatment
Key inclusion criteria (5 listed)
- Are currently taking coumadin (warfarin)
- Are aged 18 years or older
- Able and willing to provide informed consent
- Can understand (read and write) English
- Required to provide a capillary sample as part of their routine medical check
Key exclusion criteria (1 listed)
- Previously 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
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
Time frame: Five days to collect data and up to two weeks to generate correlation graph
To determine the correlation of PT/INR values between an experimental and commercial device
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 17 Jun 2011.
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.
Richard Ward, Pharm.D principal investigator
Harding University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clotting Disorders, run by Universal Biosensors Pty Ltd at 1 site 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 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 17 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 1 site 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?
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device (time frame: Five days to collect data and up to two weeks to generate correlation graph). 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 17 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.