Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Recruiting now · Phase 3

Conditions studied: Traumatic Brain Injury (TBI) Patients

In brief

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.

Key facts

Study ID

NCT06953674

Run by

University of Louisville

People needed

600

Starts

2025-06-01

Expected to finish

2029-09-01

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Louisville Hospital — Louisville, Kentucky, United States (enrolling)

Full record on ClinicalTrials.gov

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