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Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Normal Saline (0.9% NaCl) (drug)
• balanced crystalloid (drug)

Sponsor: University of Louisville · Participants: 600 · Started: Jun 1, 2025

Contact the study team

• Mechelle Kaufman, BSN, RN · Phone: 502-588-2329

Official record on ClinicalTrials.gov — NCT06953674

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.