Venous ThromboembolismEPIGETBO IIINCT02895971
Incidence of Venous Thromboembolism and Professional Practices in Brest Area
An observational study of Venous Thromboembolism, run by University Hospital, Brest at 1 site in France.
Trial summary
The aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 1,416 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2013to 30 Jun 2017
- 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: Patient with venous thromboembolism
Who may be able to join
- symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) diagnosis confirmed
- Patient living in Brest area from time of diagnosis
Who cannot join
- invalid diagnosis
- asymptomatic event
- Main residence patient out of Brest area.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, professional Practices
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken.
After two years, all medication given to the patient to treat his initial VTE will be recorded, as well as the ongoing of thromboembolic disease
Measured: two years after VTE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start4 Mar 2013
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895971
- Sponsor's protocol ID
- EPIGETBO III (RB 12.157)
- Acronym
- EPIGETBO III
- Status last verified
- Jul 2017
- First submitted
- 29 Aug 2016
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Thromboembolism and Professional Practices in Brest Area
- ClinicalTrials.gov ID
- NCT02895971
- Acronym / sponsor ID
- EPIGETBO III / EPIGETBO III (RB 12.157)
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism, professional Practices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 4 Mar 2013 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 12 Sep 2016 (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 aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with venous thromboembolism
Key inclusion criteria (2 listed)
- symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) diagnosis confirmed
- Patient living in Brest area from time of diagnosis
Key exclusion criteria (3 listed)
- invalid diagnosis
- asymptomatic event
- Main residence patient out of Brest area.
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
Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken.
Time frame: two years after VTE
After two years, all medication given to the patient to treat his initial VTE will be recorded, as well as the ongoing of thromboembolic disease
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 5 Jul 2017.
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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.
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 Venous Thromboembolism, run by University Hospital, Brest at 1 site in France.
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 2 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 5 Jul 2017. 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 France. 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?
Gathering information about potential factors predisposing Thromboembolic disease and treatments undertaken. (time frame: two years after VTE). 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 5 Jul 2017.