Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
University of Louisville Hospital
RECRUITING
Louisville
Contact Information
Primary
Mechelle Kaufman, BSN, RN
mechelle.kaufman@louisville.edu
502-588-2329
Backup
Akshitkumar Mistry, M.D.
a.mistry@uoflhealth.org
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2029-09
Participants
Target number of participants: 600
Treatments
Experimental: Normal Saline
normal saline (0.9% sodium chloride) administered intravenously
Active_comparator: Isotonic Crystalloid
balanced crystalloid intravenous fluid therapy
Related Therapeutic Areas
Sponsors
Leads: University of Louisville
Collaborators: Kentucky Spinal Cord and Head Injury Research Board

This content was sourced from clinicaltrials.gov