Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial with Blinded Evaluation of the Primary Outcome

What this Trial Is About

Researchers are evaluating the use of early continuous intravenous infusion of hypertonic saline solution (HSS) in patients with traumatic brain injury (TBI) who are at high risk of increased pressure inside the skull (intracranial hypertension). The study aims to determine if this treatment can improve survival and help patients regain independence in daily activities six months after injury. This is a phase 3, randomized, controlled clinical trial with blinded evaluation of the main outcomes. Participants are randomly assigned to one of two groups: one receiving continuous infusion of HSS (20% sodium chloride) for 48 hours, which can be extended if intracranial hypertension continues, and the other receiving standard care without this infusion. The treatment is given early after monitoring of intracranial pressure is established. The study is conducted across multiple centers and is single-blinded. During the trial, patients will be closely monitored in intensive care units. Researchers will assess neurological recovery, the control of intracranial hypertension, quality of life, memory function, and treatment tolerance over various time points up to 12 months. Genetic biomarkers and cost-effectiveness analyses will also be evaluated. The primary outcomes focus on the efficacy of early continuous HSS infusion at 3 and 6 months. Safety and additional neurological assessments will be conducted for up to a year after treatment.

Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.