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Hip Fracture and Patent Foramen Ovale (COL-FOP)

Primary Purpose

Hip Fractures

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Transthoracic echocardiography

About this trial

This is an interventional diagnostic trial for Hip Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

hip fracture requiring a surgical procedure

Exclusion Criteria:

simultaneous other traumatic lesion

Sites / Locations

Institut Hospitalier Franco-Britannique
CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

detection of a patent foramen ovale

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Number of days before walking without help

Number of days at home during the first postoperative year

Number of days of stay at home

Mortality

Full Information

NCT ID

NCT02564133

First Posted

September 29, 2015

Last Updated

August 8, 2017

Sponsor

Hopital Foch

1. Study Identification

Unique Protocol Identification Number

NCT02564133

Brief Title

Hip Fracture and Patent Foramen Ovale

Acronym

COL-FOP

Official Title

Are Postoperative Complications More Frequent When Patients Having a Hip Fracture Have a Patent Foramen Ovale ?

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

We have discovered a too low prevalence of Patent Foramen Ovale compared to the theoretical % of around 20-25%.

Study Start Date

June 2013 (undefined)

Primary Completion Date

April 26, 2017 (Actual)

Study Completion Date

April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hopital Foch

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

detection of a patent foramen ovale

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Transthoracic echocardiography

Intervention Description

A transthoracic echocardiography is performed to discover a patent foramen ovale

Primary Outcome Measure Information:

Title

Number of participants with postoperative complications probably related to the presence of a patent foramen ovale

Description

Complications probably related to the presence of a patent foramen ovale

Time Frame

First postoperative week

Secondary Outcome Measure Information:

Title

Number of participants with postoperative complications probably not related to the presence of a patent foramen ovale

Description

Complications probably not related to the presence of a patent foramen ovale

Time Frame

First postoperative week

Title

Number of days before walking without help

Time Frame

One year

Title

Number of days at home during the first postoperative year

Description

Number of days of stay at home

Time Frame

one year

Title

Mortality

Time Frame

Three months and one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: hip fracture requiring a surgical procedure Exclusion Criteria: simultaneous other traumatic lesion

Facility Information:

Facility Name

Institut Hospitalier Franco-Britannique

City

Levallois-Perret

ZIP/Postal Code

92300

Country

France

Facility Name

CHU

City

Rennes

ZIP/Postal Code

35000

Country

France

12. IPD Sharing Statement

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Hip Fracture and Patent Foramen Ovale

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