Transatlantic registry of type A aortic dissection
| ISRCTN | ISRCTN26697221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26697221 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 363388 |
| Protocol serial number | Nil known |
| Sponsor | Helsinki University Hospital |
| Funder | Helsingin ja Uudenmaan Sairaanhoitopiiri |
- Submission date
- 22/10/2025
- Registration date
- 29/12/2025
- Last edited
- 29/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as an emergency or salvage procedure and is associated with increased postoperative early mortality and morbidity. Although early mortality has declined over the last years, it remains significant in Western countries. The Nordic Consortium for Acute Type A Aortic Dissection registry, including 1189 patients operated on from 2005 to 2015 in 8 centers showed that 30-day mortality after surgery for acute TAAD was 18%. The multicenter, prospective German Registry for Acute Aortic Dissection Type A, including 2137 TAAD patients operated from 2006 and 2010, documented a 30-day mortality of 16.9%. A more recent analysis of the Society of Thoracic Surgeons database, including 7353 patients operated on from 2014 and 2017 for acute TAAD, reported a 30-day mortality of 17%. Furthermore, surgery for TAAD is often complicated by major adverse events such as stroke and acute kidney failure, which may have a significant impact on late survival. In this scenario of significant postoperative mortality and morbidity, surgeons face the controversial issue of the extent of surgical repair for acute TAAD by avoiding a major surgical repair with its possible increased risk of early adverse events. However, limited aortic repair may expose the patient to the risk of late complications at the level of the aortic root, the aortic arch and/or the downstream aorta. We planned the multicenter Transatlantic Registry of Type A Aortic Dissection (TARTAAD) for a thorough evaluation of the early and late outcomes of acute TAAD after different surgical and perfusion strategies in patients operated at several European and North American cardiac surgery centers.
Who can participate?
Adult patients aged > 18 years with TAAD or intramural hematoma involving the aortic root/ascending aorta; symptoms started within 7 days before surgery; primary surgical repair of acute TAAD; any other major cardiac surgical procedure concomitant with surgery for TAAD.
What does the study involve?
Patients who underwent surgical repair for acute TAAD.
What are the possible benefits and risks of participating?
There are no known benefits or risks to participants.
Where is the study run from?
This is a multicenter study. The sponsor center is the Helsinki University Hospital, Helsinki, Finland.
When is the study starting and how long is it expected to run for?
March 2025 to February 2026
Who is funding the study?
Helsinki University Central Hospital, Finland
Who is the main contact?
1. Fausto Biancari, MD, PhD, fausto.biancari@hus.fi
2. Tatu Juvonen, MD, PhD, tatu.juvonen@hus.fi
Contact information
Public, Scientific
Heart and Lung Center
Helsinki University Hospital
Haartmaninkatu 4
Helsinki
00029
Finland
 ORCID ID |
0000-0001-5028-8186 |
|---|---|
| Phone | +393474837339 |
| fausto.biancari@hus.fi |
Principal investigator
Heart and Lung Center
Helsinki University Hospital
Haartmaninkatu 4
Helsinki
00029
Finland
| ORCID ID |
0000-0002-9934-756X |
|---|---|
| Phone | +358504080562 |
| tatu.juvonen@hus.fi |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational multicenter cohort study registry |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Transatlantic registry of Type A aortic dissection |
| Study acronym | TARTAAD |
| Study objectives | Primary objective: to identify the predictors influencing early and late mortality in TAAD patients undergoing open heart surgery Secondary objectives: to elucidate and identify predictors of: 1) Re-exploration for bleeding 2) Cerebrovascular accident 3) Surgical site infection 4) Blood transfusion 5) Acute kidney injury 6) Length of intensive care unit (ICU) stay 7) Length of hospital stay 8) Reoperation after hospital discharge 9) Late survival 10) Rate of late re-intervention |
| Ethics approval(s) |
Approved 16/05/2025, Helsinki University Hospital (Marjaniementie 74, Iiris-keskus, Helsinki, PL 200, 00029 HUS, Finland; +358504287837; kirjaamo@hus.fi), ref: HUS/95/2025 |
| Health condition(s) or problem(s) studied | Type A aortic dissection |
| Intervention | Patients included in this registry are those who underwent surgery for type A aortic dissection. Surgical repair of this severe condition is the only treatment available to prevent aortic rupture. Surgery consists of resection and replacement with a vascular prosthesis of the ascending aorta as well as the aortic root and/or the aortic arch. Surgical treatment was performed in university and non-university cardiac surgery units. Since the delay from the onset of symptoms to surgical treatment may increase the risk of further extension of the dissection to the aortic branches or may lead to aortic rupture, emergency surgery is usually performed in these patients. The extension of aortic repair may depend on the site and extent of the aortic tear and may vary according to institutional and individual surgeon’s policy. The type of aortic repair might have varied during the study period, and we expect that a policy of more extensive aortic repair has been pursued during the last years. The duration of observation of this study is 14 years (from January 2010 to December 2024) and the duration of follow-up is 16 years (from May 2010 to February 2026). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Mortality measured using hospital records, national database and/or contacting patients, their relatives or general practitioners, until the last follow-up control |
| Key secondary outcome measure(s) |
1. Stroke or global brain ischemia measured using hospital records during the index hospital stay |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 10000 |
| Total final enrolment | 10000 |
| Key inclusion criteria | 1. Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta 2. Patients aged > 18 years 3. Symptoms started within 7 days before surgery 4. Primary surgical repair of acute TAAD 5. Any other major cardiac surgical procedure concomitant with surgery for TAAD |
| Key exclusion criteria | 1. Patients aged < 18 years 2. Onset of symptoms > 7 days from surgery 3. Prior procedure for TAAD 4. Type non-A non-B aortic dissection 5. Retrograde TAAD (with primary tear located in descending aorta) 6 Concomitant endocarditis 7. TAAD secondary to blunt or penetrating chest trauma |
| Date of first enrolment | 16/05/2025 |
| Date of final enrolment | 28/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Belgium
- Czech Republic
- Finland
- France
- Germany
- Hungary
- Italy
- Netherlands
- Spain
- United States of America
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
England
Glenfield
Leicester
LE3 8GS
England
Liverpool
L14 3PE
England
Tremona Road
Southampton
SO16 6YD
England
Derriford Road
Derriford
Plymouth
PL6 8DH
England
Cambridge Biomedical Campus
Cambridge
CB2 0AY
England
London
SE1 7EH
England
Helsinki
00029
Finland
Hamburg
20251
Germany
Rotterdam
3015
Netherlands
Köln
50937
Germany
Reims
51100
France
Dijon
21079
France
Varese
21100
Italy
Halle
06108
Germany
Munich
80539
Germany
Barcelona
08036
Spain
Prague
10034
Czech Republic
Trieste
34148
Italy
Ústí nad Labem-Severní
40011
Czech Republic
Muenster
48149
Germany
Madrid
28007
Spain
Kuopio
70210
Finland
Turku
20520
Finland
Cincinnati
OH 45267
United States of America
Valhalla
NY 10595
United States of America
Detroit
48202
United States of America
Verona
37126
Italy
Bruxelles
1200
Belgium
Maastricht
6229 HX
Netherlands
Madrid
28222
Spain
Mainz
55131
Germany
Budapest
1122
Hungary
Aachen
52074
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 01/05/2025 | 23/10/2025 | No | No | |
| Protocol file | 30/10/2025 | No | No |
Additional files
- 48257_Protocol_v.1.0b_01May2025.pdf
- Protocol file
- 48257_PROTOCOL.pdf
- Protocol file
Editorial Notes
30/10/2025: Study's existence confirmed by the Erasmus Medical Center and the Westchester Medical Center of the New York Medical College.
