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Clinical Trials/NCT04831073
NCT04831073
Completed
Not Applicable

European Registry of Type A Aortic Dissection

Helsinki University Central Hospital20 sites in 8 countries3,902 target enrollmentFebruary 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type A Aortic Dissection
Sponsor
Helsinki University Central Hospital
Enrollment
3902
Locations
20
Primary Endpoint
Mortality rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Detailed Description

Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.

Registry
clinicaltrials.gov
Start Date
February 28, 2023
End Date
December 6, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fausto Biancari

Professor

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

  • Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta;
  • Patients aged \> 18 years:
  • Symptoms started within 7 days from surgery;
  • Primary surgical repair of acute type A aortic dissection;
  • Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection.

Exclusion Criteria

  • Patients aged \< 18 years;
  • Onset of symptoms \> 7 days from surgery;
  • Prior procedure for type A aortic dissection;
  • Retrograde type A aortic dissection (with primary tear located in the descending aorta);
  • Concomitant endocarditis;
  • Type A aortic dissection secondary to blunt or penetrating chest trauma.

Outcomes

Primary Outcomes

Mortality rate

Time Frame: During the index hospital stay until last follow-up control

All-cause mortality

Cumulative incidence of reoperation on the aorta

Time Frame: During the index hospital stay until last follow-up control

Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication

Secondary Outcomes

  • Incidence and amount of blood transfusion(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of stroke(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of reoperation for bleeding(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of acute kidney injury(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Length of stay in the intensive care unit(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of paraplegia/paraparesis(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of surgical site infection(From date of procedure until the date of hospital discharge, assessed up to 3 months)
  • Incidence of global brain ischemia(From date of procedure until the date of hospital discharge, assessed up to 3 months)

Study Sites (20)

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