- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04408404
Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital
May 28, 2020 updated by: MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic.
Global mortality remains high even if it decreased last years.
This is probably due to improvement of diagnostic techniques and the evolution of surgical practices.
It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
230
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dijon, France, 21000
- Cardiovascular and thoracic surgery Unit - Dijon University Hopital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.
Description
Inclusion Criteria:
- patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital
Exclusion Criteria:
- patients who died before the surgical incision
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type A aortic dissection
Patient operated for type A acute aortic dissection between 01 January 2007 and 31 December 2017 in Dijon Burgundy University Hospital
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Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitor peri-operative mortality incidence rates
Time Frame: 1 day
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Mortality during peri-operative acute aortic dissection procedure
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitor peri-operative morbidity incidence rates
Time Frame: 1 day
|
Stroke, Kidney failure, Reexploration for bleeding
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
May 26, 2020
Study Registration Dates
First Submitted
May 26, 2020
First Submitted That Met QC Criteria
May 28, 2020
First Posted (Actual)
May 29, 2020
Study Record Updates
Last Update Posted (Actual)
May 29, 2020
Last Update Submitted That Met QC Criteria
May 28, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCVT- Dissection
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study.
No data shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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