CT-Angiography Versus Angiogram as Ancillary Tests in the Determination of Death by Neurologic Criteria (Tadaa)

March 15, 2026 updated by: Peter Rudberg, Region Stockholm

A Comparison of Computed Tomography-Angiography Versus Four-vessel Angiography in the Determination of Brain Death

Diagnostic performance of a novel protocol for computed tomography-angiography, as ancillary test in the determination of complete cerebral infarction, in comparison to four vessel angiography.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

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

  • Name: Anja Rosén, M.D.
  • Phone Number: 94856 +46-8-12370000
  • Email: anja.rosen@ki.se

Study Contact Backup

  • Name: Peter C Rudberg, M.D. Ph.D.
  • Phone Number: 72341 +46-8-1237000
  • Email: peter.rudberg@ki.se

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska University Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving critical care

Description

Inclusion Criteria:

  • Adults 18 years or older
  • Ongoing critical care due to severe acute brain injury
  • Four vessel angiography necessary for the determination of complete cerebral infarction, according to Swedish legislation

Exclusion Criteria:

  • Treatment with extracorporeal membrane oxygenation (ECMO)
  • Radiologic examination by computed tomography deemed too challenging due to respiratory or circulatory instability, as determined by responsible clinician

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

Cohorts and Interventions

Group / Cohort
Suspected Complete Cerebral Infarction
Patients with severe acute brain injury, in whom complete cerebral infarction has been declared by direct neurological criteria, but ancillary testing is warranted due to specific circumstances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance similar between computed tomography-angiography and four vessel angiography
Time Frame: Periprocedural
Sensitivity, specificity, positive predictive value, negative predictive value, inter- and intrarater variability.
Periprocedural

Collaborators and Investigators

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

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

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)

January 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-4056

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Observational, exploratory

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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