Deep Vein ThrombosisNCT00867646
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
An observational study of Deep Vein Thrombosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Aug 2008
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 Warfarin teated patients
Who may be able to join
- Warfarin continuously treated patients
Who cannot join
- Warfarin recently discontinuous treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study of CoaguChek XS Prothrombin Time and Laboratory Innovin PT by NTUH Lab Medicine
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
Read the detailed description
This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek system and the laboratory reference method. This preliminary study is intended to help familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an indicator as to whether some of the variables. Evaluation Phase consists of testing seventy (70) patient samples with the CoaguChek XS system and with the laboratory method.
- Conditions
- Deep Vein Thrombosis
- Keywords
- PT, DVT
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the PTINR measured by Coaguchek and laboratory CA1500
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chiang Fu-Tien, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867646
- Sponsor's protocol ID
- 20080418R
- Status last verified
- Dec 2009
- First submitted
- 1 Aug 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of CoaguChek XS Prothrombin Time and Laboratory Innovin PT by NTUH Lab Medicine
- ClinicalTrials.gov ID
- NCT00867646
- Acronym / sponsor ID
- 20080418R
- Conditions
- Deep Vein Thrombosis
- Keywords
- PT, DVT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Mar 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.
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine
Detailed description
This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek system and the laboratory reference method. This preliminary study is intended to help familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an indicator as to whether some of the variables. Evaluation Phase consists of testing seventy (70) patient samples with the CoaguChek XS system and with the laboratory method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 Warfarin teated patients
Key inclusion criteria (1 listed)
- Warfarin continuously treated patients
Key exclusion criteria (1 listed)
- Warfarin recently discontinuous treatment
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
Comparison of the PTINR measured by Coaguchek and laboratory CA1500
Time frame: 2 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 15 Dec 2009.
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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.
Chiang Fu-Tien, PhD study director
National Taiwan University Hospital
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 Deep Vein Thrombosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 15 Dec 2009. 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 Taiwan. 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?
Comparison of the PTINR measured by Coaguchek and laboratory CA1500 (time frame: 2 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 15 Dec 2009.