European Registry of Type A Aortic Dissection
- Conditions
- Type A Aortic Dissection
- Interventions
- Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch
- Registration Number
- NCT04831073
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3902
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute type A aortic dissection Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch Patients who underwent surgery for acute type A aortic dissection
- Primary Outcome Measures
Name Time Method Mortality rate During the index hospital stay until last follow-up control All-cause mortality
Cumulative incidence of reoperation on the aorta 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 Outcome Measures
Name Time Method Incidence of stroke From date of procedure until the date of hospital discharge, assessed up to 3 months 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.
Incidence of reoperation for bleeding From date of procedure until the date of hospital discharge, assessed up to 3 months Chest reopening for excessive bleeding.
Incidence of acute kidney injury From date of procedure until the date of hospital discharge, assessed up to 3 months 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
Incidence and amount of blood transfusion From date of procedure until the date of hospital discharge, assessed up to 3 months Transfusions of red blood cells
Length of stay in the intensive care unit From date of procedure until the date of hospital discharge, assessed up to 3 months Duration of stay in the intensive care unit
Incidence of paraplegia/paraparesis From date of procedure until the date of hospital discharge, assessed up to 3 months Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion.
Incidence of surgical site infection From date of procedure until the date of hospital discharge, assessed up to 3 months Proven infection involving deep sternal wound tissues and/or mediastinum.
Incidence of global brain ischemia From date of procedure until the date of hospital discharge, assessed up to 3 months Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.
Trial Locations
- Locations (20)
Saint-Luc's Hospital
🇧🇪Brussels, Belgium
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
University Hospitals Leuven
🇧🇪Leuven, Belgium
Helsinki University Hospital
🇫🇮Helsinki, Finland
University of Udine
🇮🇹Udine, Italy
University of Verona Medical School
🇮🇹Verona, Italy
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
AZ St-Jan
🇧🇪Brugge, Belgium
University Hospital Antwerp
🇧🇪Edegem, Belgium
Institute of Clinical and Experimental Medicine
🇨🇿Prague, Czechia
Henri Mondor University Hospital
🇫🇷Créteil, Paris, France
Münster University Hospital
🇩🇪Münster, Germany
University Heart & Vascular Centre Hamburg
🇩🇪Hamburg, Germany
Leipzig Heart Center
🇩🇪Leipzig, Germany
University Hospital Jean Minjoz
🇫🇷Besançon, France
University of Torino
🇮🇹Torino, Italy
Hospital ClÃnic de Barcelona
🇪🇸Barcelona, Spain
University Hospitals of Leicester
🇬🇧Leicester, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom