Saline, Not Albumin, for Patients with Head Injury

The Saline versus Albumin Fluid Evaluation (SAFE) study was a randomized, double-blind comparison of saline and albumin in a heterogeneous population of intensive care unit patients. The study showed no difference in outcomes between treatment groups but suggested an increased death rate in patients with traumatic brain injury who received albumin. However, the trial was not directed specifically toward patients with head injury.

Researchers reevaluated data from the SAFE study for patients with traumatic brain injury (SAFE-TBI study), using specific measures of injury severity, including Glasgow Coma Scale (GCS) score and intracranial pressure. In addition, whereas the original study measured outcomes up to 28 weeks after admission, this study measured outcomes (death and disability) at 24 months.

Of 460 patients with traumatic brain injury, 69% had severe injury (GCS score of 3–8). At 24 months, 33.2% of the albumin group had died, as compared to 20.4% of the saline group. This difference was due to a marked disparity in survival in the subgroup of patients with severe head injury; mortality rates were 41.8% in those treated with albumin and 22.2% in those treated with saline (relative risk, 1.88). Among survivors, neurologic outcomes were similar in the two treatment groups.