Actively Recruiting
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Led by University of Louisville · Updated on 2025-08-17
600
Participants Needed
1
Research Sites
221 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
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.
CONDITIONS
Official 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 of 12 or less
- Head CT showing skull fracture(s) and/or brain hemorrhage(s) larger than 1 cm with trauma mechanism reported
You will not qualify if you...
- Severe abdominal or chest trauma causing higher mortality risk than brain injury
- Brain injury considered non-survivable by the treating physician
- Emergency surgery for visceral injury before full trauma assessment
- Suspected ruptured brain blood vessel malformation
- Patients transferred from another hospital
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Akshitkumar Mistry, M.D.
CONTACT
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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