European Registry of Type A Aortic Dissection (ERTAAD)

December 6, 2024 updated by: Fausto Biancari, Helsinki University Central Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3902

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ St-Jan
      • Brussels, Belgium
        • Saint-Luc's Hospital
      • Edegem, Belgium
        • University Hospital Antwerp
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Leuven, Belgium
        • University Hospitals Leuven
  • Czechia
      • Prague, Czechia
        • Institute of clinical and experimental medicine
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
  • France
      • Besançon, France
        • University Hospital Jean Minjoz
    • Paris
      • Créteil, Paris, France
        • Henri Mondor University Hospital
  • Germany
      • Hamburg, Germany
        • University Heart & Vascular Centre Hamburg
      • Leipzig, Germany
        • Leipzig Heart Center
      • Münster, Germany
        • Munster University Hospital
  • Italy
      • Torino, Italy
        • University of Torino
      • Udine, Italy
        • University of Udine
      • Verona, Italy
        • University Of Verona Medical School
  • Spain
      • Barcelona, Spain
        • Hospital Clínic de Barcelona
  • United Kingdom
      • Leicester, United Kingdom
        • University Hospitals of Leicester
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital
      • Sheffield, United Kingdom
        • Northern General Hospital
      • Southampton, United Kingdom
        • Southampton University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Acute type A aortic dissection
Patients who underwent surgery for acute type A aortic dissection
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: During the index hospital stay until last follow-up control
All-cause mortality
During the index hospital stay until last follow-up control
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
During the index hospital stay until last follow-up control

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From date of procedure until the date of hospital discharge, assessed up to 3 months
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
From date of procedure until the date of hospital discharge, assessed up to 3 months
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.
From date of procedure until the date of hospital discharge, assessed up to 3 months
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.
From date of procedure until the date of hospital discharge, assessed up to 3 months
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
From date of procedure until the date of hospital discharge, assessed up to 3 months
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
From date of procedure until the date of hospital discharge, assessed up to 3 months
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.
From date of procedure until the date of hospital discharge, assessed up to 3 months
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.
From date of procedure until the date of hospital discharge, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assistance Publique - Hôpitaux de Paris
Universitaire Ziekenhuizen KU Leuven
Azienda Ospedaliera Universitaria Integrata Verona
University Hospital Muenster
Institute for Clinical and Experimental Medicine
Centre Hospitalier Universitaire de Besancon
University Hospitals, Leicester
University Hospital, Antwerp
AZ Sint-Jan AV
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
University of Turin, Italy
University Hospital Southampton NHS Foundation Trust
Ziekenhuis Oost-Limburg
Liverpool Heart and Chest Hospital NHS Foundation Trust
University of Hamburg-Eppendorf
Heart Center Leipzig - University Hospital
University of Barcelona
University Hospital, Udine, Italy
Northern General Hospital, Herries Road, Sheffield

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fausto Biancari, Helsinki University Hospital, Helsinki, Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100968

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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