European Registry of Type A Aortic Dissection

Type A Aortic Dissection Clinical Trial

— ERTAAD  

Official title:

European Registry of Type A Aortic Dissection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04831073
• Other study ID #: 100968
• Status: Active, not recruiting
• Start date: February 28, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3902
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Type A Aortic Dissection

Intervention

Procedure:
• Surgery 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

Locations

Country	Name	City	State
Belgium	AZ St-Jan	Brugge
Belgium	Saint-Luc's Hospital	Brussels
Belgium	University Hospital Antwerp	Edegem
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	University Hospitals Leuven	Leuven
Czechia	Institute of Clinical and Experimental Medicine	Prague
Finland	Helsinki University Hospital	Helsinki
France	University Hospital Jean Minjoz	Besançon
France	Henri Mondor University Hospital	Créteil	Paris
Germany	University Heart & Vascular Centre Hamburg	Hamburg
Germany	Leipzig Heart Center	Leipzig
Germany	Münster University Hospital	Münster
Italy	University of Torino	Torino
Italy	University of Udine	Udine
Italy	University of Verona Medical School	Verona
Spain	Hospital Clínic de Barcelona	Barcelona
United Kingdom	University Hospitals of Leicester	Leicester
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	Southampton University Hospital	Southampton

Sponsors (20)

Lead Sponsor

Collaborator

Helsinki University Central Hospital

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

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	All-cause mortality	During the index hospital stay until last follow-up control
Primary	Cumulative incidence of reoperation on the aorta	Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication	During the index hospital stay until last follow-up control
Secondary	Incidence of stroke	change 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.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence of acute kidney injury	It 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	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence of surgical site infection	Proven infection involving deep sternal wound tissues and/or mediastinum.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence of reoperation for bleeding	Chest reopening for excessive bleeding.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence and amount of blood transfusion	Transfusions of red blood cells	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Length of stay in the intensive care unit	Duration of stay in the intensive care unit	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence of global brain ischemia	Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.	From date of procedure until the date of hospital discharge, assessed up to 3 months
Secondary	Incidence of paraplegia/paraparesis	Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion.	From date of procedure until the date of hospital discharge, assessed up to 3 months