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Clinical Trials in Italy / NCT04459806
Recruiting Observational

Intracranial PrEssure Time dOse (ImPETO)

NCT04459806 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Milano Bicocca
Phase
Observational
Started
2023-11-13
Last updated
2025-09-15

Condition(s) studied

Intracranial HypertensionTraumatic Brain InjurySubarachnoid HemorrhageIntracranial Hemorrhages

Investigational drug(s) / intervention(s)

intracranial pressure monitoring

intracranial pressure monitoring: Invasive monitoring of intracranial pressure by using CereLink monitor.

Study summary

The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting.

Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS San Gerardo dei Tintori Monza MB Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04459806 on ClinicalTrials.gov ↗ ← All trials in Italy