Hip FracturesCOL-FOPNCT02564133
Hip Fracture and Patent Foramen Ovale
A study testing Transthoracic echocardiography in people with Hip Fractures, run by Hopital Foch at 2 sites in France.
Trial summary
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin. A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Transthoracic echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2013to 26 Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- hip fracture requiring a surgical procedure
Who cannot join
- simultaneous other traumatic lesion
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Hospitalier Franco-Britannique
Levallois-Perret, 92300
CHU
Rennes, 35000
About this study
Official title: Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.
A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.
The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.
- Conditions
- Hip Fractures
- Being tested
- Transthoracic echocardiography
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDevice
A transthoracic echocardiography is performed to discover a patent foramen ovale
| Study group | Role | What they receive |
|---|---|---|
| detection of a patent foramen ovale | Experimental | Not described Receives: Device: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale
Complications probably related to the presence of a patent foramen ovale
Measured: First postoperative week
Secondary outcomes (4)
Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale
Complications probably not related to the presence of a patent foramen ovale
Measured: First postoperative week
Number of days before walking without help
Measured: One year
Number of days at home during the first postoperative year
Number of days of stay at home
Measured: one year
Mortality
Measured: Three months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJun 2013
- Primary completion26 Apr 2017
- Study completion26 Apr 2017
Why it stopped: We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564133
- Sponsor's protocol ID
- 2012/35
- Other IDs
- 2012-A01155-38
- Acronym
- COL-FOP
- Status last verified
- Aug 2017
- First submitted
- 29 Sep 2015
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?
- ClinicalTrials.gov ID
- NCT02564133
- Acronym / sponsor ID
- COL-FOP / 2012/35
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 26 Apr 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 30 Sep 2015 (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.
Ereth et al. showed in 1992, using transesophageal echocardiography, that the implantation of a hip prosthesis may be complicated by intracardiac embolization of various origin.
A patent foramen ovale exists in approximately one fifth of the population; it facilitates the passage of embolus from the right heart to the left one and then especially to the coronary vessels and to the brain.
The hypothesis supported in this research is that the prevalence of postoperative complications, especially neurological ones, is increased after surgery for hip fracture when patients have a patent foramen ovale.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| detection of a patent foramen ovale | Experimental | Device: Transthoracic echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hip fracture requiring a surgical procedure
Key exclusion criteria (1 listed)
- simultaneous other traumatic lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyA transthoracic echocardiography is performed to discover a patent foramen ovale | Device | detection of a patent foramen ovale |
Primary outcome
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale
Time frame: First postoperative week
Complications probably related to the presence of a patent foramen ovale
4 secondary outcomes
Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale
Time frame: First postoperative week
Number of days before walking without help
Time frame: One year
Number of days at home during the first postoperative year
Time frame: one year
Mortality
Time frame: Three months and one year
Results and safety
The study was stopped early (reason given: We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic echocardiography in people with Hip Fractures, run by Hopital Foch at 2 sites 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 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: stopped early, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.). 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?
Number of participants with postoperative complications probably related to the presence of a patent foramen ovale (time frame: First postoperative week). 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 Aug 2017.