Saline versus balanced crystalloid fluids for moderate-to-severe traumatic brain injury
Official title: Saline vs. Balanced Crystalloid in Traumatic Brain Injury
Run by University of Louisville · NCT06953674 · Data updated 2026-11-12
This will test whether giving saline or a balanced crystalloid fluid to people with moderate-to-severe traumatic brain injury leads to better recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 2029 |
| Study ends | September 2029 |
| Registry record updated | August 26, 2026 |
| Trial ID | NCT06953674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are trauma patients presenting directly to the University of Louisville emergency department with moderate-to-severe TBI (GCS ≤12) and CT evidence of skull fracture or intracranial hemorrhage >1 cm.
✕Probably not a fit
Patients with non-survivable brain injury, dominant life-threatening visceral trauma requiring immediate surgery, suspected ruptured intracranial vascular malformation, or those transferred from another facility are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with moderate-to-severe TBI (Glasgow Coma Scale ≤12 and head CT showing skull fracture or intracranial hemorrhage >1 cm) receive either normal saline or a balanced crystalloid through an IV during early hospitalization. Clinical data including vital signs, laboratory values, and treatments are collected from the medical record from admission through day 14 or discharge. A short follow-up survey at six months captures final disability. Outcomes in the two fluid groups are compared to see which fluid is associated with improved recovery.
Why it matters
Potential benefit: If successful, identifying the better fluid could reduce disability and improve recovery after moderate-to-severe TBI.
How similar studies have gone: Large critical care trials have shown modest benefits of balanced crystalloids over saline in general ICU populations, but evidence specific to TBI is limited and inconclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Louisville Hospital
Louisville, Kentucky, United States Recruiting
Study contacts
- Principal investigator: Akshitkumar Mistry, MD — Assistant Professor Term
- Study coordinator: Mechelle Kaufman, BSN, RN
- Email: mechelle.kaufman@louisville.edu
- Phone: 502-588-2329
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.