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NCT Number: NCT04831073

European Registry of Type A Aortic Dissection

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.

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Key information

Conditions

Type A Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ St-Jan, Bruges, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Mortality rate

    Time frame: During the index hospital stay until last follow-up control

    All-cause mortality

  2. Cumulative incidence of reoperation on the aorta

    Time frame: 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 outcomes

  1. Incidence of stroke

    Time frame: 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.

  2. Incidence of acute kidney injury

    Time frame: 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

  3. Incidence of surgical site infection

    Time frame: 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.

  4. Incidence of reoperation for bleeding

    Time frame: From date of procedure until the date of hospital discharge, assessed up to 3 months

    Chest reopening for excessive bleeding.

  5. Incidence and amount of blood transfusion

    Time frame: From date of procedure until the date of hospital discharge, assessed up to 3 months

    Transfusions of red blood cells

  6. Length of stay in the intensive care unit

    Time frame: From date of procedure until the date of hospital discharge, assessed up to 3 months

    Duration of stay in the intensive care unit

  7. Incidence of global brain ischemia

    Time frame: 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.

  8. Incidence of paraplegia/paraparesis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • AZ Sint-Jan AV
  • Assistance Publique - Hôpitaux de Paris
  • 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

Registry information

Acronym: ERTAAD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 5, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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