Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Launched by UNIVERSITY OF LOUISVILLE · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring which type of fluid—saline or balanced crystalloids—works better for patients with moderate to severe traumatic brain injury (TBI). The main goal is to find out if using one kind of fluid can lead to better health outcomes for these patients. If you or a loved one is eligible and chooses to participate, you will receive either saline or balanced fluid through an IV while in the hospital. Researchers will closely monitor your vital signs and health data from the first day of your hospital stay until you are either discharged or for up to 14 days. Then, six months later, a follow-up survey will help assess any lasting effects of the injury.

To be eligible for this trial, participants must be trauma patients arriving at the emergency room with a Glasgow Coma Scale score of 12 or lower, which indicates the severity of the brain injury. They should also have a head CT showing skull fractures or bleeding. However, individuals with certain severe injuries or those who have already undergone major surgery or treatment before being fully assessed will not be included in the trial. This study is important as it aims to improve how we treat TBI patients, potentially leading to better recovery and quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Trauma patients presenting to the Emergency Room for initial care
• • Glasgow Coma Scale ≤ 12
• • Head CT with skull fracture(s) and/or hemorrhage(s) (\>1cm in any single dimension) with a reported mechanism of trauma
• Exclusion Criteria:
• • Severe visceral trauma dictating mortality (visceral injury severity score \> brain injury severity score)
• • Non-survivable brain injury based on the treating physician's judgment
• • Emergent visceral operative intervention before complete trauma assessment
• • Concern for ruptured intracranial vascular malformation
• • Patients who are transferred from another facility