Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT04459806

Intracranial PrEssure Time dOse (ImPETO)

Led by University of Milano Bicocca · Updated on 2025-09-15

250

Participants Needed

1

Research Sites

163 weeks

Total Duration

On this page

Sponsors

U

University of Milano Bicocca

Lead Sponsor

I

Integra LifeSciences Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intracranial PrEssure Time dOse (ImPETO)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged within 18 and 80 years
  • Diagnosed with an acute brain injury (ABI) including hemorrhagic stroke (intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury
  • ICP monitoring started for clinical indication according to local policies
  • ICP device connected to the Integra CereLink ICP monitor
Not Eligible

You will not qualify if you...

  • ICP monitoring not inserted
  • No availability of the Integra CereLink ICP monitor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy, 20900

Actively Recruiting

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Research Team

G

Giuseppe Citerio, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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