Severe blunt traumatic brain injury (TBI) is a major cause of mortality and long-term disability in previously healthy young adults. The current standard of initial surgical care includes evacuation of intracranial hematomas, and, often amputation of swollen confused brain. The rationale for the latter intervention is that further edema in this area of presumed unsalvageable cerebrum will cause intracranial hypertension, impeding blood flow to otherwise more health areas of brain, with resultant infarction. To this end, modern neuro-tensive care expends great effort to control intracranial pressure (ICP) and prevent such secondary injury. While effectively reducing ICP, past non-randomized investigations have employed hemicraniectomy at later times, for refractory ICP, and have lacked standardized surgical and/or medical protocols and outcome measures. This randomized pilot study seeks to address the safety and possibly preliminary efficacy of early hemicraniectomy (as the initial surgical intervention) for managing patients with severe TBI. Goals include: 1) reduced therapeutic intensity for ICP over a shorter length of stay (LOS), 2) reduced need for repeat computer tomography (CT) scans and returns to the operating room (OR), and 3) improved neurological outcome. The study will randomly assign, within 24 hours of ictus, 92 TBI patients, Glasgow Coma Scale score less than or equal to 9, with midline shift greater than the size of a surgically removable hematoma. Group I will receive standardized hemicraniectomy; Group II will undergo traditional craniotomy with or without brain amputation, at the discretion of the attending neurosurgeon. I both groups, hematomas greater than or equal to 20 cc will be evacuated, a standardized medical protocol will be followed, and daily monitoring will assess neurological status and ICU therapeutic intensity. The primary outcome measure is the six-month Glasgow Outcome Scale. Secondary outcome measures include the Disability Rating Scale, Functional Independence Measures, and the SF-36 Health Survey o to one year after TBI (to assess quality of live for survivors), the duration and frequency of elevated ICP episodes, ICE Therapeutic Intervention Severity Scores, returns to CT and the OR, and ICU and hospital LOS. We hypothesize that, while both surgical therapies will initially effectively treat intracranial hypertension, the hemicraniectomy group will experience improved neurological outcome, and a reduced intensity of cre to control ICP. These data will prepare us for a full-scale multi-center outcome study of early hemicraniectomy.
