Nordic Consortium for Acute Type A Aortic Dissection-2

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

The Nordic Consortium for Acute Type A Aortic Dissection-2 (NORCAAD-2) is a multicenter research collaboration involving up to 19 units in the Nordic countries and one in The Netherlands. All patients referred for this condition is included, to outline detailed preoperative characteristics and risk factors as well as, for those operated, data on the operative procedure, the postoperative course including major and minor complications and, as the primary interest, mortality in short- and long-term perspective. The need for further procedures on the aorta will also be studied.

Acute type A Aortic Dissection (ATAAD) is a vascular emergency with very high case-fatality rate. The condition is realtively infrequent, and single units can rarely amass sufficient number of patients during a reasonable time to analyse also unusual variants in background, presentation, and management. Randomized controlled trials are unlikely, and large multicenter databases are the best source of knowledge for the foreseeable future. Other such databases exist, but NORCAAD-2 is more focused (only ATAAD) and more detailed than many counterparts, with the ability to extract unique information.

NORCAAD-2 is the extension and expansion of the original NORCAAD project. NORCAAD-2 includes more centers, more patients, more data and utilizes a novel on-line common database designed for the purpose.

The ultimate goal is to identify novel risk markers to help inform decisions on pre-emptive surgery (before ATAAD occurs); to outline superior perioperative techniques and strategies to optimize outcomes both short- and long-term; and to analyze variables related to major complications, in an effort to further reduce their incidence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute (within 14 days of onset) type A aortic dissection or similar acute aortic syndrome

Disqualifiers

Age <18 years at onset

Trial population

All patients with acute type A aortic dissection referred to any of the participating centers

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • surgery

    Procedure/Surgery

    Open heart surgery

  • endovascular intervention

    Procedure/Surgery

    Aortic endovascular intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Early mortality

Mortality within 30 days of referral or operation

Time frame
30 days

Secondary outcomes

1

Late mortality

Mortality late after referral or operation

Time frame
>30 days
2

Reintervention

Any reintervention (endovascular, open surgical) on the aorta

Time frame
throughout study period

Other outcomes

1

Permanent neurological damage

Stroke or spinal cord infarction with permament neurological symptoms

Time frame
30 days
2

Temporary neurological damage

Transitory ischemic attack, minor stroke, coma or unconsciousness, confusion or other new neurological symptoms resolving before discharge

Time frame
30 days
3

Renal insufficiency

Renal insufficiency (as graded and described by various classification systems)

Time frame
30 days
4

Re-exploration

Re-exploration for control of bleeding or tamponade

Time frame
72 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Aarhus University Hospital Skejby

Collaborator

Haukeland University Hospital

Collaborator

Rigshospitalet, Denmark

Collaborator

Helsinki University Central Hospital

Collaborator

Kuopio University Hospital

Collaborator

Leiden University Medical Center

Collaborator

Skane University Hospital

Collaborator

Odense University Hospital

Collaborator

Oslo University Hospital

Collaborator

Landspitali University Hospital

Collaborator

Norrlands University Hospital

Collaborator

Tampere University Hospital

Collaborator

Turku University Hospital

Collaborator

Trondheim University Hospital

Collaborator

University Hospital, Linkoeping

Collaborator

Vastra Gotaland Region

Collaborator

Uppsala University Hospital

Collaborator

Blekinge County Council Hospital

Collaborator

Örebro University, Sweden

Collaborator

Riga Stradins University

Collaborator