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New brain pressure monitor could predict patient outcomes

NCT ID NCT04459806

Knowledge-focused Sponsor: University of Milano Bicocca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study is testing a new monitor that tracks brain pressure over time in patients with serious brain injuries like trauma or bleeding. Researchers want to see if the pressure measurements can predict who will survive or recover well. The study will enroll 250 adults and follow their outcomes in the hospital and after 6 months.

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 help doctors better predict which brain injury patients are at risk of poor outcomes, guiding more timely treatments.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear link between the new measurement and patient outcomes, or the findings may not change current care.

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

About 250 people

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

Started

Nov 2023

Expected to finish

Dec 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.

Who is studied

Patients with an acute brain injury (ABI) due to hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury.

Ages

18 to 80 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: * Aged within 18 and 80 years; * Diagnosed of an acute brain injury (ABI) for hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury; * ICP monitoring started for clinical indication and accordingly to local policies * ICP device connected to the Integra CereLink ICP monitor. Exclusion Criteria: * ICP monitoring not inserted * No availability of the Integra CereLink ICP monitor.

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic intracerebral hemorrhage Intracranial Hemorrhages intracranial hypertension subarachnoid hemorrhage traumatic brain injury

As listed by the trial registrant

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

Intracranial hemorrhages Intracranial hypertension Subarachnoid hemorrhage Traumatic brain injury

How to take part

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

  1. The places running it

    1 site. 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

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, MB, 20900, Italy

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