NCT04459806Recruiting
Intracranial PrEssure Time dOse (ImPETO)
Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 1 Jul 2020
- Start date
- 13 Nov 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- University of Milano Bicocca
- Diseases
- High blood pressure
- NCT number
- NCT04459806
What you commit to
- Study type: Observational
- Planned participants: 250
- From 13 Nov 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- ICP monitoring not inserted
- No availability of the Integra CereLink ICP monitor.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.