Intracranial PrEssure Time dOse (ImPETO) (NCT04459806) | Clinical Trial Compass
RecruitingNot Applicable
Intracranial PrEssure Time dOse (ImPETO)
Italy250 participantsStarted 2023-11-13
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying something called 'pressure time dose' — can you explain what that means and how it relates to my specific diagnosis, whether it's a brain bleed or a traumatic brain injury?
2Since this study is listed as Phase NA, it sounds like it's focused on observing and measuring data rather than testing a new treatment — does that mean my care wouldn't change if I were enrolled, and I'd just be having my intracranial pressure data collected?
3The trial is measuring how pressure time dose connects to in-hospital mortality — is this the kind of data-collection study where the findings might help future patients more than it directly helps me right now, and how should I weigh that?
4Given that this trial covers several different conditions like subarachnoid hemorrhage, traumatic brain injury, and intracranial hemorrhages, would my specific diagnosis make me a good or poor fit for what the researchers are trying to learn?
5What monitoring or data recording would actually be done on me as part of this study, and would it require any extra procedures beyond what I'd already be having for my standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between PTD and in-hospital mortality.