Comparing Saline and Balanced Fluids for Treatment of Moderate to Severe Traumatic Brain Injury

What this Trial Is About

Researchers are evaluating which type of crystalloid fluid, saline or balanced crystalloid, should be used in the emergency and hospital care of adults with moderate to severe traumatic brain injury TBI. The goal is to determine if one fluid type is linked to better neurological outcomes six months after injury. This Phase 3 trial focuses on patients with TBI who have a Glasgow Coma Scale score of 12 or less and specific head CT findings. Participants will receive either normal saline 0.9% sodium chloride or balanced crystalloid fluids intravenously during their hospital stay, starting in the emergency room and continuing until discharge or up to 14 days. The amount, rate, and timing of fluid administration will be managed by the treating medical team according to usual care, with adherence ensured through pharmacy and physician orders. During hospitalization, vital signs, lab results, treatments, and other medical data will be collected from medical records. Six months after injury, participants will complete a brief survey lasting about five minutes to assess their final neurological disability. The main outcome measured is neurological status at six months post-injury, with inpatient mortality tracked until hospital discharge, usually within two weeks. The total study involvement spans from emergency care through a six-month follow-up.

Saline Versus Balanced Crystalloid in Traumatic Brain Injury