NCT06953674PHASE3Recruiting

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

University of Louisville

Start Date

6/1/2025

Completion Date

9/1/2029

Summary

The goal of this clinical trial is to determine which crystalloid (saline or balanced) should be used in the critical management of Traumatic Brain Injury (TBI) in moderate or severe TBI patients. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients. Participants will 1. be given fluids through the veins, either saline or balanced fluid will be given. 2. From the first day to the day 14 of the hospitalization (or discharge, whichever comes first), vital signs, laboratory values, treatments given, and other medical data will be collected from the medical record. 3. Six months later, your final disability, if any, will be assessed during your follow-up with a doctor. It involves answering a short survey that will take about 5 minutes or less.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Normal Saline (0.9% NaCl)

DRUG

balanced crystalloid

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Conditions

Traumatic Brain Injury (TBI) Patients

Locations

University of Louisville Hospital

Louisville, Kentucky 40202

United States