Clinical trial NCT04831073: European Registry of Type A Aortic Dissection
Official title: European Registry of Type A Aortic Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type A Aortic Dissection
Keywords: Aortic dissection
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
name: University Hospital Southampton NHS Foundation Trust
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Centre Hospitalier Universitaire de Besancon
name: Assistance Publique - Hôpitaux de Paris
name: Ziekenhuis Oost-Limburg
name: University Hospital Muenster
name: University of Hamburg-Eppendorf
name: Institute for Clinical and Experimental Medicine
name: Northern General Hospital, Herries Road, Sheffield
name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: University Hospital, Udine, Italy
name: Heart Center Leipzig - University Hospital
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: AZ Sint-Jan AV
name: University Hospital, Antwerp
name: Universitaire Ziekenhuizen KU Leuven
name: University of Turin, Italy
name: University of Barcelona
First posted: 2021-04-05
Enrollment: 3902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta.

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.

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.

Primary outcomes:
measure: Mortality rate
timeFrame: During the index hospital stay until last follow-up control
measure: Cumulative incidence of reoperation on the aorta
timeFrame: During the index hospital stay until last follow-up control
Secondary outcomes:
measure: Incidence of stroke
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence of acute kidney injury
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence of surgical site infection
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence of reoperation for bleeding
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence and amount of blood transfusion
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Length of stay in the intensive care unit
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence of global brain ischemia
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
measure: Incidence of paraplegia/paraparesis
timeFrame: From date of procedure until the date of hospital discharge, assessed up to 3 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ St-Jan
city: Brussels
country: Belgium
facility: Saint-Luc's Hospital
city: Edegem
country: Belgium
facility: University Hospital Antwerp
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Prague
country: Czechia
facility: Institute of Clinical and Experimental Medicine
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Créteil
country: France
facility: Henri Mondor University Hospital
state: Paris
city: Besançon
country: France
facility: University Hospital Jean Minjoz
city: Hamburg
country: Germany
facility: University Heart & Vascular Centre Hamburg
city: Leipzig
country: Germany
facility: Leipzig Heart Center
city: Münster
country: Germany
facility: Münster University Hospital
city: Torino
country: Italy
facility: University of Torino
city: Udine
country: Italy
facility: University of Udine
city: Verona
country: Italy
facility: University of Verona Medical School
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Helsinki University Hospital, Helsinki, Finland
name: Fausto Biancari
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5.