Intracranial pressure and surgical decompression for traumatic brain injury: biological rationale and protocol for a randomized clinical trial.

Commonly, severe traumatic brain injury (TBI) patients undergo amputation of contused brain; the rationale being that edema in presumed unsalvageable cerebrum increases intracranial pressure (ICP). Neuro-critical care expends great effort to control ICP and prevent secondary injury. Non-randomized investigations have employed hemicraniectomy with duraplasty after developing refractory ICP. We undertook a randomized pilot of hemicraniectomy with duraplasty as the initial surgery for severe TBI patients. Goals included reduced ICP therapeutic intensity and return to the operating room, and improved neurological outcome. Upon hospital presentation, the study was to randomize 92 patients with midline shift greater than the size of a surgically removable hematoma. One group was to receive standardized hemicraniectomy and duraplasty; the other would undergo 'traditional' craniotomy (with brain amputation at the neurosurgeon's discretion). A standardized medical protocol followed. The six-month Glasgow Outcome Scale was the primary outcome, with secondary measures including quality of life one year after TBI, duration and frequency of elevated ICP, intensive care unit (ICU) therapeutic intensity, operating room return, and ICU and hospital lengths-of-stay. This article presents the biological rationale and the evidence-based standardized protocols of the study and its outcome measures. The study has stopped and a phase III outcome trial is being organized.

RCT Entities:   Population Interventions Outcomes