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New study tests better way to drain brain bleeds after surgery

NCT ID NCT06621407

Disease control Sponsor: Aalborg University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of drainage after surgery for chronic subdural hematoma (a blood collection on the brain). 354 adults in Denmark will receive either active drainage under the scalp or passive drainage under the brain's outer layer for 24 hours. The goal is to see which method better prevents the hematoma from coming back and reduces death within 90 days.

What this could mean

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

Active substance
drainage procedure (active subperiosteal or passive subdural)
What this could lead to
If active drainage works better, it could lower the chance of the hematoma coming back and reduce deaths after surgery.
What could go wrong
This is a non-inferiority trial, so it may only show that active drainage is not worse than the standard method, not that it is better. Results are limited to a specific surgical technique and may not apply to all patients.

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 354 people

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

Started

Sep 2025

Expected to finish

Nov 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 years and older

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: * Adult patients (≥ 18 years). * Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment. * Patients undergoing a single burr-hole evacuation. * Informed written and oral consent is taken prior to surgery. Exclusion Criteria: * Patients who are mentally incapacitated * Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type) * Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt. * Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess). * Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason) * Patients unable to give consent prior to surgery

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Conditions

The condition(s) this trial relates to.

cerebrospinal fluid leak Hematoma, Subdural, Chronic Recurrence

As listed by the trial registrant

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

Chronic subdural hematoma Drainage Drainage procedure Drainage/methods Mortality Recurrence Surgical procedures, operative

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Neurosurgery, Aalborg University Hospital

    RECRUITING

    Aalborg, 9000, Denmark

  • Department of Neurosurgery, Aarhus University Hospital

    RECRUITING

    Aarhus, 8000, Denmark

  • Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Department of Neurosurgery, Odense University Hospital

    RECRUITING

    Odense, 5100, Denmark

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