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Brain bleed surgery: does the drill site matter?

NCT ID NCT07731620

Disease control Sponsor: The Second Hospital of Anhui Medical University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial compares two common puncture sites—frontal region versus parietal eminence—for minimally invasive twist-drill drainage of chronic subdural hematoma (a slow brain bleed common in older adults). The goal is to see which site lowers the risk of the hematoma coming back and needing another surgery within three months. Adults with a unilateral chronic subdural hematoma who need surgical drainage are randomly assigned to one of the two puncture sites and followed for recovery and complications.

What this could mean

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

Active substance
twist-drill puncture and closed-system drainage at either the frontal region or the parietal eminence
What this could lead to
If one puncture site proves better, it could become the standard approach for this common brain-bleed surgery, lowering the chance that patients need a second operation.
What could go wrong
This is a single-center trial, so results may not apply everywhere. The outcome depends on surgical technique and patient anatomy, and recurrence can still happen regardless of site.

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 440 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

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: 1. Age ≥ 18 years. 2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI. 3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness. 4. Radiological indication for surgery, defined as one of the following: Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon. 5. Plan to undergo twist-drill puncture drainage with a closed drainage system. 6. Written informed consent signed by the participant or their legally authorized representative. Exclusion Criteria: 1. Bilateral cSDH requiring simultaneous bilateral surgery. 2. Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component. 3. Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively. 4. Previous surgery on the ipsilateral side for cSDH. 5. Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm. 6. Severe coagulation disorder that cannot be corrected before surgery. 7. Life expectancy \< 6 months. 8. Pregnancy. 9. Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.

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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

How to take part

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

  1. The places running it

    3 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

  • Huai'an First People's Hospital

    Huai'an, Jiangsu, 223300, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • Yangzhou University Affiliated Hospital

    Yangzhou, Jiangsu, 225009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.