Blood Coagulation DisordersNCT01349712
Study to Test the Accuracy of a Prototype Handheld PT/INR Device
An observational study of Blood Coagulation 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) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Disorders
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 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: Subjects currently receving coumadin(warfarin) treatment
Who may be able to join
- Currently taking coumadin (warfarin)
- Aged 18 years or older
- Able and willing to provide informed consent
- Can understand (read and write) English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Diagnostic Clinic
Batesville, Arkansas, 72501
About this study
Official title: Correlation of Feasibility Batches Using Warfarinised Blood
The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.
Read the detailed description
This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.
- Conditions
- Blood Coagulation Disorders
- Medical subject headings
- Blood Coagulation 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 are required to be 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: Fives 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 posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation 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
- 200 participants (estimated)
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
- NCT01349712
- Sponsor's protocol ID
- MOB 0158
- Status last verified
- May 2011
- First submitted
- 29 Apr 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Feasibility Batches Using Warfarinised Blood
- ClinicalTrials.gov ID
- NCT01349712
- Acronym / sponsor ID
- MOB 0158
- Conditions
- Blood Coagulation Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universal Biosensors Pty LtdIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 9 May 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) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.
Detailed description
This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both 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 are required to be 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 receving coumadin(warfarin) treatment
Key inclusion criteria (4 listed)
- Currently taking coumadin (warfarin)
- Aged 18 years or older
- Able and willing to provide informed consent
- Can understand (read and write) English
Key exclusion criteria (1 listed)
- None
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: Fives 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
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 Blood Coagulation 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 4 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: status not confirmed, as of the sponsor's last update on 9 May 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?
Results are not available in the source record.
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: Fives 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 9 May 2011.