Study Stopped
We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.
Hip Fracture and Patent Foramen Ovale
COL-FOP
Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?
2 other identifiers
interventional
41
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2017
CompletedAugust 9, 2017
August 1, 2017
3.9 years
September 29, 2015
August 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
First postoperative week
Secondary Outcomes (4)
Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale
First postoperative week
Number of days before walking without help
One year
Number of days at home during the first postoperative year
one year
Mortality
Three months and one year
Study Arms (1)
detection of a patent foramen ovale
EXPERIMENTALInterventions
A transthoracic echocardiography is performed to discover a patent foramen ovale
Eligibility Criteria
You may qualify if:
- hip fracture requiring a surgical procedure
You may not qualify if:
- simultaneous other traumatic lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
Institut Hospitalier Franco-Britannique
Levallois-Perret, 92300, France
CHU
Rennes, 35000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
September 30, 2015
Study Start
June 1, 2013
Primary Completion
April 26, 2017
Study Completion
April 26, 2017
Last Updated
August 9, 2017
Record last verified: 2017-08