Type A Aortic Dissection Clinical Trial
— ERTAADOfficial title:
European Registry of Type A Aortic Dissection
Verified date | February 2023 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
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 |
Belgium, Czechia, Finland, France, Germany, Italy, Spain, United Kingdom,
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 |
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