Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Monitoring intracranial pressure to assess patient outcomes

Official title: Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor

Run by University of Milano Bicocca · NCT04459806 · Data updated 2026-11-12

This study is testing if continuous monitoring of pressure inside the skull can help doctors understand how well patients with serious brain injuries are doing and predict their recovery.

More Traumatic Brain Injury trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment250 (estimated)
SponsorUniversity of Milano Bicocca
Academic / other
Locations1 site (Monza, MB)
StatusRecruiting
StartedNovember 13, 2023
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 15, 2025
Trial IDNCT04459806 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 80 diagnosed with acute brain injuries such as hemorrhagic stroke or traumatic brain injury requiring ICP monitoring.

Probably not a fit

Patients who do not have an ICP monitor inserted or those not connected to the Integra CereLink ICP monitor will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the clinical utility of continuous intracranial pressure (ICP) monitoring using the Integra CereLink ICP monitor. It aims to determine if the Pressure Time Dose (PTD) metric, derived from continuous ICP recordings, correlates with patient outcomes in individuals with acute brain injuries. The study will identify a threshold of PTD that signifies a transition from favorable to unfavorable outcomes, thereby enhancing the understanding of ICP monitoring in neurocritical care. The research is grounded in existing guidelines and seeks to address gaps in current ICP monitoring practices.

Why it matters

Potential benefit: If successful, this study could improve patient outcomes by establishing effective ICP monitoring thresholds for better management of acute brain injuries.

How similar studies have gone: While ICP monitoring is a common practice, this specific approach to evaluating PTD in non-traumatic brain injuries is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fondazione IRCCS San Gerardo dei Tintori
    Monza, Mb, Italy
    Recruiting

Study contacts

  • Principal investigator: Giuseppe Citerio, Professor — University of Milano Bicocca
  • Study coordinator: Giuseppe Citerio, Professor
  • Email: giuseppe.citerio@unimib.it
  • Phone: +39039233

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.