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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, MB) |
| Status | Recruiting |
| Started | November 13, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT04459806 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.