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European Registry of Type A Aortic Dissection

European Registry of Type A Aortic Dissection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04831073
Acronym
ERTAAD
Enrollment
3902
Registered
2021-04-05
Start date
2023-02-28
Completion date
2024-12-06
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type A Aortic Dissection

Keywords

Aortic dissection

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.

Interventions

PROCEDURESurgery on the ascending aorta with or without repair of the aortic root and/or aortic arch

Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch

Sponsors

University Hospitals, Leicester
CollaboratorOTHER
University Hospital Southampton NHS Foundation Trust
CollaboratorOTHER
Azienda Ospedaliera Universitaria Integrata Verona
CollaboratorOTHER
Centre Hospitalier Universitaire de Besancon
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Ziekenhuis Oost-Limburg
CollaboratorOTHER
University Hospital Muenster
CollaboratorOTHER
University of Hamburg-Eppendorf
CollaboratorOTHER
Institute for Clinical and Experimental Medicine
CollaboratorOTHER_GOV
Northern General Hospital, Herries Road, Sheffield
CollaboratorUNKNOWN
Liverpool Heart and Chest Hospital NHS Foundation Trust
CollaboratorOTHER
University Hospital, Udine, Italy
CollaboratorOTHER
Heart Center Leipzig - University Hospital
CollaboratorOTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
CollaboratorOTHER
AZ Sint-Jan AV
CollaboratorOTHER
University Hospital, Antwerp
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
University of Turin, Italy
CollaboratorOTHER
University of Barcelona
CollaboratorOTHER
Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality rateDuring the index hospital stay until last follow-up controlAll-cause mortality
Cumulative incidence of reoperation on the aortaDuring the index hospital stay until last follow-up controlAny surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication

Secondary

MeasureTime frameDescription
Incidence of surgical site infectionFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsProven infection involving deep sternal wound tissues and/or mediastinum.
Incidence of reoperation for bleedingFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsChest reopening for excessive bleeding.
Incidence and amount of blood transfusionFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsTransfusions of red blood cells
Incidence of strokeFrom date of procedure until the date of hospital discharge, assessed up to 3 monthschange in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR \<24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death.
Incidence of global brain ischemiaFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsDiffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.
Incidence of paraplegia/paraparesisFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsBilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion.
Length of stay in the intensive care unitFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsDuration of stay in the intensive care unit
Incidence of acute kidney injuryFrom date of procedure until the date of hospital discharge, assessed up to 3 monthsIt will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Countries

Belgium, Czechia, Finland, France, Germany, Italy, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026