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Blocking a scalp artery could replace surgery for bleeding on the brain

NCT ID NCT05267184

Disease control Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Chronic subdural hematoma is a buildup of blood between the brain and its outer covering, common in older adults. Standard treatment drains the blood through a hole in the skull, but the hematoma often returns and needs another operation. This Swedish trial randomly assigns 288 adults to either standard surgical drainage or a less invasive procedure that blocks the middle meningeal artery with liquid embolic agents. Researchers compare how often each group needs a repeat operation, along with disability, quality of life, and how much blood remains.

What this could mean

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

Active substance
Embolization of the middle meningeal artery using liquid embolic agents
What this could lead to
If it works, blocking the middle meningeal artery could offer a less invasive way to treat chronic subdural hematoma and reduce the need for repeat surgery.
What could go wrong
This is a head-to-head comparison, not a proven treatment. Embolization carries risks of stroke or bleeding, and it may not match surgery for clearing the hematoma or preventing reoperation.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Sep 2027

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.

Ages

18 to 89 years

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: 1. Men and women 18-89 y/o 2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH 3. Clinical and/or radiological status indicating neurosurgical treatment 4. Markwalder Scale score \<2 5. Glasgow coma Scale score \>13 6. Able to provide signed informed consent Exclusion Criteria: 1. Acute subdural hematoma 2. Focal, non-hemispheric cSDH 3. Midline shift \>10 mm and/or effaced basal cisterns and/or significant dilatation of one or both lateral ventricle temporal horns and/or incipient uncal herniation 4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt) 5. Contraindications to angiography 6. Dependency defined as mRS \>3 7. Life expectancy \<6 months 8. Comorbidity deemed making follow up impossible 9. Participation in other interventional clinical study 10. Pregnancy

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

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

Chronic subdural hematoma

Contacts and locations

Locations

  • Karolinska Hospital

    Stockholm, 17176, Sweden

  • Norrlands Universitetssjukhus

    Umeå, 90737, Sweden

  • Sahlgenska University Hospital

    Gothenburg, 41345, Sweden

  • Skåne University Hospital

    Lund, 22185, Sweden

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