About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ICP monitoring not inserted
No availability of the Integra CereLink ICP monitor.
Trial population
Patients with an acute brain injury (ABI) due to hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury.
Trial design
Cohort
Prospective
Treatments tested in this trial
intracranial pressure monitoring
Procedure/SurgeryInvasive monitoring of intracranial pressure by using CereLink monitor.
Treatment groups
Trial outcomes
Primary outcomes
Association between PTD and in-hospital mortality.
To assess the association between PTD and in-hospital mortality.
Secondary outcomes
Association between PTD and 6 months GOSE
To assess the association between PTD and 6 months GOSE (Glasgow Outcome Scale extended).
PTD summary measure.
To identify the PTD summary measure (e.g. mmHg/h max, mmHg/day, mmHg/week) that maximize the outcome prediction.
Outcome predictiveness of PTD and end hour ICP.
To compare the outcome predictiveness of PTD and end hour ICP.
Sponsors and contacts
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University of Milano Bicocca
Lead sponsor
Integra LifeSciences Corporation
Collaborator