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European Registry of Type A Aortic Dissection

NCT ID: NCT04831073

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3902 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-28

Study Completion Date

2024-12-06

Brief Summary

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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

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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.

Conditions

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Type A Aortic Dissection

Keywords

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Aortic dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Acute type A aortic dissection

Patients who underwent surgery for acute type A aortic dissection

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals, Leicester

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role collaborator

University of Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role collaborator

Northern General Hospital, Herries Road, Sheffield

UNKNOWN

Sponsor Role collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospital, Udine, Italy

OTHER

Sponsor Role collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University of Turin, Italy

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fausto Biancari

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fausto Biancari

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Hospital, Helsinki, Finland

Locations

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AZ St-Jan

Bruges, , Belgium

Site Status

Saint-Luc's Hospital

Brussels, , Belgium

Site Status

University Hospital Antwerp

Edegem, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

University Hospitals Leuven

Leuven, , Belgium

Site Status

Institute of Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Henri Mondor University Hospital

Créteil, Paris, France

Site Status

University Hospital Jean Minjoz

Besançon, , France

Site Status

University Heart & Vascular Centre Hamburg

Hamburg, , Germany

Site Status

Leipzig Heart Center

Leipzig, , Germany

Site Status

Münster University Hospital

Münster, , Germany

Site Status

University of Torino

Torino, , Italy

Site Status

University of Udine

Udine, , Italy

Site Status

University of Verona Medical School

Verona, , Italy

Site Status

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status

University Hospitals of Leicester

Leicester, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Northern General Hospital

Sheffield, , United Kingdom

Site Status

Southampton University Hospital

Southampton, , United Kingdom

Site Status

Countries

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Belgium Czechia Finland France Germany Italy Spain United Kingdom

References

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Demal TJ, Knochenhauer T, Weimann J, Juvonen T, Makikallio T, Fiore A, Perrotti A, Pettinari M, Peterss S, Buech J, Radner C, Dell'Aquila AM, Wisniewski K, Pol M, Kacer P, Onorati F, Francica A, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Lega JR, Pinto AG, Acharya M, Field M, Kuduvalli M, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, D'Errigo P, Mariscalco G, El-Dean Z, Detter C, Reichenspurner H, Polvani G, Biancari F, Conradi L. Outcome after day- and nighttime surgery for acute type A aortic dissection. Eur J Cardiothorac Surg. 2025 Jun 3;67(6):ezaf192. doi: 10.1093/ejcts/ezaf192.

Reference Type DERIVED
PMID: 40569847 (View on PubMed)

Biancari F, Makikallio T, Rosato S, Juvonen T, Mariscalco G, El-Dean Z, Acharya M, Pettinari M, Rodriguez-Lega J, Pinto AG, Perrotti A, Onorati F, Wisniewski K, Conradi L, Demal T, Pol M, Rocek J, Kacer P, Gatti G, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Peterss S, Buech J, Radner C, Field M, Harky A, Fiore A, Senemaud J, Mustonen C, Dell'Aquila AM, D'Errigo P, Polvani G, Di Perna D. Carotid artery dissection and neurological complications after surgery for type 1 aortic dissection. Open Heart. 2025 Mar 12;12(1):e002882. doi: 10.1136/openhrt-2024-002882.

Reference Type DERIVED
PMID: 40081929 (View on PubMed)

Biancari F, Fileccia D, Ferrante L, Makikallio T, Juvonen T, Jormalainen M, Mariscalco G, El-Dean Z, Pettinari M, Rodriguez Lega J, Pinto AG, Perrotti A, Onorati F, Wisniewski K, Demal T, Kacer P, Rocek J, Di Perna D, Vendramin I, Piani D, Rinaldi M, Quintana E, Pruna-Guillen R, Peterss S, Buech J, Radner C, Kuduvalli M, Harky A, Fiore A, D'Alonzo M, Dell'Aquila AM, Gatti G, Conradi L, Ballotta A, Field M. Extent of surgical repair and outcomes after surgery for type A aortic dissection. BJS Open. 2025 Mar 4;9(2):zraf003. doi: 10.1093/bjsopen/zraf003.

Reference Type DERIVED
PMID: 40071739 (View on PubMed)

Biancari F, Gatti G, Makikallio T, Juvonen T, Mariscalco G, El-Dean Z, Pettinari M, Rodriguez Lega J, Perrotti A, Onorati F, Wisniewki K, Demal T, Kacer P, Perna DD, Vendramin I, Rinaldi M, Ferrante L, Quintana E, Buech J, Radner C, Fiore A, Dell'Aquila AM, D'Errigo P, Rosato S, Polvani G, Peterss S. Ascending aortic replacement versus aortic root replacement in patients with type A aortic dissection involving the aortic root. Ther Adv Cardiovasc Dis. 2025 Jan-Dec;19:17539447241303408. doi: 10.1177/17539447241303408.

Reference Type DERIVED
PMID: 39840731 (View on PubMed)

Biancari F, Lega JR, Mariscalco G, Peterss S, Buech J, Fiore A, Perrotti A, Rukosujew A, Pinto AG, Demal T, Wisniewski K, Pol M, Gatti G, Vendramin I, Rinaldi M, Pruna-Guillen R, Di Perna D, El-Dean Z, Sherzad H, Nappi F, Field M, Pettinari M, Jormalainen M, Dell'Aquila AM, Onorati F, Quintana E, Juvonen T, Makikallio T. Aortic arch surgery for DeBakey type 1 aortic dissection in patients aged 60 years or younger. BJS Open. 2024 May 8;8(3):zrae047. doi: 10.1093/bjsopen/zrae047.

Reference Type DERIVED
PMID: 38768283 (View on PubMed)

Juvonen T, Vendramin I, Mariscalco G, Jormalainen M, Perrotti A, Herve A, Mazzaro E, Gatti G, Pettinari M, Peterss S, Buech J, Nappi F, Pinto AG, Rodriguez Lega J, Pol M, Rocek J, Kacer P, Rukosujew A, Wisniewski K, Piani D, Demal T, Conradi L, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Fiore A, Folliguet T, Acharya M, El-Dean Z, Field M, Kuduvalli M, Onorati F, Francica A, Makikallio T, Dell'Aquila AM, Mustonen C, Raivio P, Rosato S, Biancari F. Femoral arterial cannulation for surgical repair of stanford type A aortic dissection. World J Surg. 2024 Jul;48(7):1771-1782. doi: 10.1002/wjs.12203. Epub 2024 Apr 30.

Reference Type DERIVED
PMID: 38686961 (View on PubMed)

Biancari F, Onorati F, Peterss S, Buech J, Mariscalco G, Lega JR, Pinto AG, Fiore A, Perrotti A, Herve A, Rukosujew A, Demal T, Conradi L, Wisniewski K, Pol M, Kacer P, Gatti G, Mazzaro E, Vendramin I, Piani D, Rinaldi M, Ferrante L, Pruna-Guillen R, Di Perna D, Gerelli S, El-Dean Z, Nappi F, Field M, Kuduvalli M, Pettinari M, Francica A, Jormalainen M, Dell'Aquila AM, Makikallio T, Juvonen T, Quintana E. Nature of Neurological Complications and Outcome After Surgery for Type A Aortic Dissection. Am J Cardiol. 2024 May 15;219:85-91. doi: 10.1016/j.amjcard.2024.03.001. Epub 2024 Mar 6.

Reference Type DERIVED
PMID: 38458584 (View on PubMed)

Biancari F, Perrotti A, Juvonen T, Mariscalco G, Pettinari M, Lega JR, Di Perna D, Makikallio T, Onorati F, Wisniewki K, Demal T, Pol M, Gatti G, Vendramin I, Rinaldi M, Quintana E, Peterss S, Field M, Fiore A. Diameter and dissection of the abdominal aorta and the risk of distal aortic reoperation after surgery for type A aortic dissection. Int J Cardiol. 2024 Jun 1;404:131938. doi: 10.1016/j.ijcard.2024.131938. Epub 2024 Mar 7.

Reference Type DERIVED
PMID: 38458387 (View on PubMed)

Biancari F, Demal T, Nappi F, Onorati F, Francica A, Peterss S, Buech J, Fiore A, Folliguet T, Perrotti A, Herve A, Conradi L, Rukosujew A, Pinto AG, Lega JR, Pol M, Rocek J, Kacer P, Wisniewski K, Mazzaro E, Vendramin I, Piani D, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Acharya M, Mariscalco G, Field M, Kuduvalli M, Pettinari M, Rosato S, D'Errigo P, Jormalainen M, Mustonen C, Makikallio T, Dell'Aquila AM, Juvonen T, Gatti G. Baseline risk factors of in-hospital mortality after surgery for acute type A aortic dissection: an ERTAAD study. Front Cardiovasc Med. 2024 Jan 15;10:1307935. doi: 10.3389/fcvm.2023.1307935. eCollection 2023.

Reference Type DERIVED
PMID: 38288052 (View on PubMed)

Juvonen T, Jormalainen M, Mustonen C, Demal T, Fiore A, Perrotti A, Herve A, Mazzaro E, Gatti G, Pettinari M, Peterss S, Buech J, Nappi F, Conradi L, Pinto AG, Rodriguez Lega J, Pol M, Kacer P, Dell'Aquila AM, Rukosujew A, Wisniewski K, Vendramin I, Piani D, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Folliguet T, Acharya M, Field M, Kuduvalli M, Onorati F, Rossetti C, Makikallio T, Raivio P, Mariscalco G, Biancari F. Direct Aortic Versus Supra-Aortic Arterial Cannulation During Surgery for Acute Type A Aortic Dissection. World J Surg. 2023 Nov;47(11):2899-2908. doi: 10.1007/s00268-023-07116-z. Epub 2023 Jul 11.

Reference Type DERIVED
PMID: 37432422 (View on PubMed)

Biancari F, Juvonen T, Fiore A, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Dell'Aquila AM, Wisniewski K, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Rodriguez Lega J, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, Raivio P, Jormalainen M, Mariscalco G. Current Outcome after Surgery for Type A Aortic Dissection. Ann Surg. 2023 Oct 1;278(4):e885-e892. doi: 10.1097/SLA.0000000000005840. Epub 2023 Mar 13.

Reference Type DERIVED
PMID: 36912033 (View on PubMed)

Biancari F, Dell'Aquila AM, Gatti G, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Wisniewski K, Juvonen T, Jormalainen M, Mustonen C, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Lega JR, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Kuduvalli M, Nappi F, Gerelli S, Di Perna D, Mazzaro E, Rosato S, Fiore A, Mariscalco G. Interinstitutional analysis of the outcome after surgery for type A aortic dissection. Eur J Trauma Emerg Surg. 2023 Aug;49(4):1791-1801. doi: 10.1007/s00068-023-02248-2. Epub 2023 Feb 24.

Reference Type DERIVED
PMID: 36826589 (View on PubMed)

Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5.

Reference Type DERIVED
PMID: 34112230 (View on PubMed)

Other Identifiers

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100968

Identifier Type: -

Identifier Source: org_study_id