Actively Recruiting
Saline vs. Balanced Crystalloid in Traumatic Brain Injury
Led by University of Louisville · Updated on 2025-08-17
600
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
K
Kentucky Spinal Cord and Head Injury Research Board
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating which type of crystalloid fluid, saline or balanced crystalloid, should be used in the emergency and hospital care of adults with moderate to severe traumatic brain injury (TBI). The goal is to determine if one fluid type is linked to better neurological outcomes six months after injury. This Phase 3 trial focuses on patients with TBI who have a Glasgow Coma Scale score of 12 or less and specific head CT findings. Participants will receive either normal saline (0.9% sodium chloride) or balanced crystalloid fluids intravenously during their hospital stay, starting in the emergency room and continuing until discharge or up to 14 days. The amount, rate, and timing of fluid administration will be managed by the treating medical team according to usual care, with adherence ensured through pharmacy and physician orders. During hospitalization, vital signs, lab results, treatments, and other medical data will be collected from medical records. Six months after injury, participants will complete a brief survey lasting about five minutes to assess their final neurological disability. The main outcome measured is neurological status at six months post-injury, with inpatient mortality tracked until hospital discharge, usually within two weeks. The total study involvement spans from emergency care through a six-month follow-up.
CONDITIONS
Brief Title
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Trauma patients presenting to the Emergency Room for initial care
- Glasgow Coma Scale score of 12 or less
- Head CT showing skull fracture(s) and/or hemorrhage(s) larger than 1 cm with a trauma mechanism reported
You will not qualify if you...
- Severe visceral trauma with injury severity score higher than brain injury severity score
- Non-survivable brain injury based on treating physician's judgment
- Emergent visceral surgery before full trauma assessment
- Concern for ruptured intracranial vascular malformation
- Patients transferred from another facility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment until hospital discharge, typically about 2 weeks
Participants receive intravenous fluid therapy with either normal saline or balanced crystalloid during emergency room care and inpatient hospitalization. The fluid administration is managed by the treating provider and continues from enrollment to hospital discharge.
Administered intravenously during hospitalization; visit frequency depends on hospital stay
Trial Site Locations
Total: 1 location
1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Actively Recruiting
Research Team
M
Mechelle Kaufman, BSN, RN
A
Akshitkumar Mistry, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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