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AI could spot deadly brain swelling before It's too late

NCT ID NCT04057690

Knowledge-focused Sponsor: University Hospital Tuebingen Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether artificial intelligence can predict malignant brain edema, a life-threatening swelling, in patients who have had a major stroke. Researchers will analyze CT scans and clinical data from over 1,600 patients to see if the AI can identify early warning signs. The goal is to help doctors act faster and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a tool that helps doctors predict and prevent severe brain swelling after a stroke, potentially saving lives.
What could go wrong
This is an observational study using existing data, not a treatment trial. The AI tool may not work perfectly in all patients or hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,687 people

The number who actually took part.

Started

Apr 2019

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

1500 retrospective datasets will be collected from 5 large German stroke units. Data sets include imaging data and clinical data from patients with subtotal MCA infarcts (M1-M2 occlusion), with or without malignant brain swelling, with or without reperfusion therapy, with or without neurosurgical decompression, and with or without death following malignant brain edema. Data sets from patients who have died following malignant brain edema will be included. Each data set consists of initial NCCT, CTA, (DSA if available), and follow-up NCCT until 14 days after stroke onset as well as clinical data.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Acute ≥ subtotal MCA infarct (M1-M2 occlusion) * with or without malignant brain swelling * with or without reperfusion therapy * with or without neurosurgical decompression * with or without death following malignant brain edema Exclusion Criteria: * Non-acute MCA infarct * \< subtotal MCA infarct

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Conditions

The condition(s) this trial relates to.

brain edema middle cerebral artery infarction stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain edema Stroke, acute

Contacts and locations

Locations

  • BRAINOMIX Limited

    Oxford, United Kingdom

  • Charité Universitätsmedizin Berlin

    Berlin, Germany

  • Fraunhofer- Gesellschaft zur Förderung der angewandten Forschung e.V., Fraunhofer MEVIS

    Bremen, Germany

  • Hertie Institute for AI in Brain Health

    Tübingen, Germany

  • Klinikum Stuttgart

    Stuttgart, Germany

  • Klinikum der Ludwig-Maximilians-Universität München

    Munich, Germany

  • Klinikum der Medizinischen Hochschule Hannover

    Hanover, Germany

  • St. John's Hospital

    Vienna, Austria

  • Technische Universität München

    Munich, Germany

  • University Hospital Tuebingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Bonn

    Bonn, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, Germany

  • Universitätsklinikum Leipzig

    Leipzig, Germany

  • Universitätsklinikum Münster

    Münster, Germany

  • Universitätsklinikum Regensburg

    Regensburg, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Germany

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