Intracranial Pressure Rescued by Decompressive Surgery after Traumatic Brain Injury.
Lori A Shutter, Shelly D Timmons
https://pubmed.ncbi.nlm.nih.gov/27604048/Actively Recruiting
Led by University of Milano Bicocca · Updated on 2025-09-15
250
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying intracranial pressure ICP monitoring in patients with acute brain injury, including hemorrhagic stroke and traumatic brain injury. This study evaluates a new Integra CereLink ICP monitor that continuously records and displays the Pressure Time Dose PTD, which measures the area under the curve of ICP over time. The goal is to determine if continuous PTD monitoring relates to patient outcomes and to identify a PTD threshold that predicts changes from good to poor outcomes. The study is a prospective, observational international cohort involving centers already using the Integra CereLink ICP monitor. It collects data from patients receiving ICP monitoring as part of their clinical care, without affecting treatment decisions. The monitor provides high-resolution ICP data, including mean ICP and PTD values. Patients will be followed for mortality and functional outcomes measured by the Glasgow Outcome Scale Extended GOSE at ICU or hospital discharge and at 6 months. Participants medical records and ICP data will be collected electronically and anonymized. Researchers will perform statistical analyses to explore associations between PTD and patient outcomes, comparing PTD with traditional hourly ICP measurements. Safety monitoring is observational, with no additional risks as no interventions are applied. The total participation includes data collection during ICU stay and follow-up at 6 months after injury.
CONDITIONS
Intracranial PrEssure Time dOse (ImPETO)
G
Giuseppe Citerio, Professor
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University of Milano Bicocca
Lead Sponsor
Integra LifeSciences Corporation
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of intracranial pressure monitoring as clinically indicated
Participants undergo invasive intracranial pressure monitoring using the Integra CereLink ICP monitor as part of routine clinical care. Data on intracranial pressure and Pressure Time Dose (PTD) are continuously recorded for clinical evaluation without affecting treatment.
Visits as per routine neurocritical care
Duration - Up to 6 months
Participants are followed up to assess clinical outcomes, including mortality and Glasgow Outcome Scale Extended (GOSE) at hospital discharge and 6 months after monitoring.
1 to 2 follow-up visits including phone interviews
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/26061135/University of Milano Bicocca
Lead Sponsor
Integra LifeSciences Corporation
Collaborating Sponsor