Factors Influencing Perioperative Mortality in Type A Acu... | NCT04408404

Studies
Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital

NCT04408404

Sponsor

Centre Hospitalier La Chartreuse

Status

Completed

Last Update Posted

May 29, 2020Actual

Enrollment

230Actual

Phase

Not provided

Conditions

Aortic Dissection

Interventions

Acute aortic dissection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

May 26, 2020Actual

First Submitted Date

May 26, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

May 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2020

Last Update Posted Date

May 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

MORGANT Marie-Catherine, Principal investigator, Centre Hospitalier La ChartreusePrincipal Investigator

Lead Sponsor

Centre Hospitalier La ChartreuseOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

230Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Procedure: Acute aortic dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acute aortic dissection	Procedure	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Monitor peri-operative mortality incidence rates	Mortality during peri-operative acute aortic dissection procedure	1 day

Secondary Outcomes

Measure	Description	Time Frame
Monitor peri-operative morbidity incidence rates	Stroke, Kidney failure, Reexploration for bleeding	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital

Exclusion Criteria:

patients who died before the surgical incision

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent aortic dissection surgery in Dijon Burgundy University Hospital since the 01 January 2007 and the 31 december 2017.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular and thoracic surgery Unit - Dijon University Hopital		Dijon		21000	France

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D000094665	Dissection, Blood Vessel
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided