Status:
RECRUITING
Intracranial PrEssure Time dOse (ImPETO)
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Integra LifeSciences Corporation
Conditions:
Intracranial Hypertension
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
Brief 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...
Detailed Description
Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care (NCCU). Its application both as a stand-alone monitoring or in association with other syst...
Eligibility Criteria
Inclusion
- 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
- ICP monitoring not inserted
- No availability of the Integra CereLink ICP monitor.
Key Trial Info
Start Date :
November 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04459806
Start Date
November 13 2023
End Date
December 31 2026
Last Update
September 15 2025
Active Locations (1)
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1
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy, 20900