Intracranial PrEssure Time dOse (ImPETO)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Milano Bicocca

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • intracranial pressure monitoring

    Procedure/Surgery

    Invasive monitoring of intracranial pressure by using CereLink monitor.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Association between PTD and in-hospital mortality.

To assess the association between PTD and in-hospital mortality.

Time frame
12 months

Secondary outcomes

1

Association between PTD and 6 months GOSE

To assess the association between PTD and 6 months GOSE (Glasgow Outcome Scale extended).

Time frame
12 months
2

PTD summary measure.

To identify the PTD summary measure (e.g. mmHg/h max, mmHg/day, mmHg/week) that maximize the outcome prediction.

Time frame
12 months
3

Outcome predictiveness of PTD and end hour ICP.

To compare the outcome predictiveness of PTD and end hour ICP.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Milano Bicocca

Lead sponsor

Integra LifeSciences Corporation

Collaborator