WEDNESDAY, Dec. 12 (HealthDay News) -- For patients with severe traumatic brain injury (TBI) treated in the intensive care unit, treatment based on maintaining monitored intracranial pressure is not superior to care based on imaging and clinical examination, according to a study published online Dec. 12 in the New England Journal of Medicine.
Randall M. Chesnut, M.D., from the University of Washington in Seattle, and colleagues conducted a multicenter trial involving 324 patients aged 13 years or older with severe TBI. The participants were randomly allocated to receive guidelines-based management, in which a protocol for monitoring intraparenchymal intracranial pressure was used, or a treatment protocol based on imaging and clinical examination.
The researchers observed no significant difference between the groups in the primary outcome, a composite measure based on 21 assessments of functional and cognitive status, and six-month mortality was also not significantly different between the groups (P = 0.60). There was no significant difference in the median length of stay in the intensive care unit between the groups, although the imaging-clinical examination group had a higher number of days of brain-specific treatments (4.8 versus 3.4; P = 0.002). There was a similar distribution of serious adverse events between the groups.
"Our data suggest that a reassessment of the role of manipulating monitored intracranial pressure as part of multimodality monitoring and targeted treatment of severe traumatic brain injury is in order," the authors write.
The study was funded in part by Integra Life Sciences; all of the study authors disclosed financial ties to Integra Life Sciences as well as to two personal injury law firms.