To qualify for consideration in the trial, patients were between the ages of 15 and 59 with a severe, nonpenetrating traumatic brain injury. The injury was defined as a score of 3 to 8 on the Glasgow Coma Scale. Patients were excluded if there were not deemed suitable for full active treatment by the clinical staff caring for the patient, or if they had dialated, unreactive pupils, mass lesions, spinal cord injury, or cardiac arrest at the scene of the injury. Within the first 72 hours after injury, patients were randomly assigned to either undergo decompressive craniectomy plus receive standard care or to receive standard care alone. In patients that were randomly chosen to undergo the decompressive craniectomy, the excised bone was stored at -70 degrees celsius, or in subcutaneous abdominal pouch. After swelling and infection had resolved, usually around 2 to 3 months after surgery, the bone was replaced.
The trial was designed to identify an increase in the proportion of favorable outcomes, defined as a score of 5 to 8 on the extended Glasgow Outcome Scale, from 30% among patients receiving standard care to 50% among patients undergoing craniectomy. Out of 3,478 patients that were assessed for eligibility, 155 patients were enrolled. The patients were randomly assigned to one of the two treatment groups: 73 were to undergo early decompressive craniectomy and 82 were to receive regular standard care. The median age for the craniectomy group was 23.7 and 24.6 for the standard care group. After randomization, fewer interventions were required to decrease intracranial pressure in patients who had undergone the craniectomy. The mean intracranial pressure was lower in the craniectomy group than in the standard care group. Patients in the craniectomy group had a shorter duration of mechanical ventilation and a shorter stay in the ICU, although there was no significant difference in the total time in the hospital in both groups. 37% of patients in the craniectomy group had a medical or surgical complication versus on 17% in the standard care group. After examination, the Extended Glasgow Outcome Scale was worse in the craniectomy patients than in the standard care patients. 70% of patients had an unfavorable outcome in the craniectomy group versus 51% in the standard care group.
Among those adults with severe diffuse traumatic brain injury with increased intracranial pressure that was resistant to regular treatment methods, the study found that the decompressive craniectomy decreased intracranial pressure, decreased the duration of mechanical ventilation, and decreased the time spent in the ICU. However, patients in the craniectomy group had a lower median score on the Glasgow Coma Scale and had a higher risk of an unfavorable outcome than those patients in the standard care group. Despite positive signs in the ICU, it was determined that decompressive craniectomy increased the likelihood of a poor outcome. It shifted survivors from a favorable outcome to and unfavorable one (i.e., dependence on assistance to complete activities of daily living). One possible explanation is that the craniectomy allowed for expansion of the swollen brain outside the skull and caused axonal stretch, which in vitro causes neural injury. Also, alterations in cerebral blood flow and metabolism may also be relevant.
Overall, the conclusions show that patients with severe diffuse traumatic brain injury and increased intracranial pressure that is resistant to regular treatment methods that undergo decompressive craniectomy have decreased intracranial pressure, decreased duration of both ventilatory support and stay in the ICU, but have a significantly worse outcome at 6 months as measured by the Extended Glasgow Outcome Scale, as compared to patients who receive the standard care treatment.
If you or a family member are seriously injured by the negligence of another and suffer a traumatic brain injury, you may need a personal injury attorney.
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