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Brain pressure sensor may guide better recovery after aneurysm rupture

NCT ID NCT06288659

Disease control Sponsor: Huashan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether using a device to continuously measure pressure inside the brain's fluid-filled spaces can improve outcomes for people who have had a bleeding stroke from a ruptured aneurysm. About 372 adults with moderate to severe bleeding will be randomly assigned to receive standard care or standard care guided by this pressure monitor. The goal is to see if more precise pressure management leads to better neurological recovery.

What this could mean

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

Active substance
Intraventricular intracranial pressure monitoring device
What this could lead to
If successful, this approach could become a standard way to manage brain pressure after aneurysm bleeding, potentially improving recovery rates.
What could go wrong
The trial is relatively small and the benefit of pressure monitoring over standard care is not yet proven. The device itself carries a small risk of infection or bleeding.

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 372 people

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

Started

Jul 2024

Expected to finish

Oct 2026

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 criterias 1. Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset. 2. Age ≥ 18 years. 3. Symptom onset within 72 hours. 4. Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging. 5. Written informed consent obtained from the participant or legal representative. Exclusion criteria included 1. Pregnancy or lactation; 2. Bilateral fixed dilated pupils on admission; 3. Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease; 4. Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3; 5. Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect; 6. Subarachnoid haemorrhage caused by non-aneurysmal aetiologies; 7. Moyamoya disease associated aneurysmal rupture; 8. Other underlying diseases expected to substantially affect prognosis; 9. Active request for ICP monitoring by the patient or family; 10. Any other condition considered unsuitable for enrolment by two investigators; 11. Concurrent participation in another clinical trial.

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage intracranial hypertension subarachnoid hemorrhage

As listed by the trial registrant

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

Aneurysmal subarachnoid hemorrhage Intacranial hypertension

Contacts and locations

Locations

  • Department of Neurosurgery, Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000, China

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