NCT04459806 Intracranial PrEssure Time dOse (ImPETO)
| NCT ID | NCT04459806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Milano Bicocca |
| Condition | Intracranial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-11-13 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-11-13 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Giuseppe Citerio, Professor
PRINCIPAL INVESTIGATOR
University of Milano Bicocca
Frequently Asked Questions
Who can join the NCT04459806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracranial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04459806 currently recruiting?
Yes, NCT04459806 is actively recruiting participants. Contact the research team at giuseppe.citerio@unimib.it for enrollment information.
Where is the NCT04459806 trial being conducted?
This trial is being conducted at Monza, Italy.
Who is sponsoring the NCT04459806 clinical trial?
NCT04459806 is sponsored by University of Milano Bicocca. The principal investigator is Giuseppe Citerio, Professor at University of Milano Bicocca. The trial plans to enroll 250 participants.