Infarction, BrainTadaaNCT07341490
CT-Angiography Versus Angiogram as Ancillary Tests in the Determination of Death by Neurologic Criteria
An observational study of Infarction, Brain, run by Region Stockholm at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infarction, Brain
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving critical care
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Peter C Rudberg, M.D. Ph.D., +46-8-12370000 ext. 72341, peter.rudberg@ki.se
Anja Rosén, M.D., +46-8-12370000 ext. 94856, anja.rosen@ki.se
About this study
Official title: 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.
- Conditions
- Infarction, Brain
- Keywords
- Cerebral infarction, Cerebral angiography, CT angiography, Brain Death, Diagnostic performance, Brain infarct
- Medical subject headings
- Brain Infarction, Cerebral Infarction, Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance similar between computed tomography-angiography and four vessel angiography
Sensitivity, specificity, positive predictive value, negative predictive value, inter- and intrarater variability.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infarction, BrainStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Peter Rudberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341490
- Sponsor's protocol ID
- 2025-4056
- Acronym
- Tadaa
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Observational, exploratory
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Computed Tomography-Angiography Versus Four-vessel Angiography in the Determination of Brain Death
- ClinicalTrials.gov ID
- NCT07341490
- Acronym / sponsor ID
- Tadaa / 2025-4056
- Conditions
- Infarction, Brain
- Keywords
- Cerebral infarction, Cerebral angiography, CT angiography, Brain Death, Diagnostic performance, Brain infarct
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving critical care
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. Observational, exploratory
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infarction, Brain, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter C Rudberg, M.D. Ph.D. (+46-8-1237000 ext. 72341, peter.rudberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance similar between computed tomography-angiography and four vessel angiography (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.