Saline versus balanced crystalloid fluids for moderate-to-severe traumatic brain injury
Saline vs. Balanced Crystalloid in Traumatic Brain Injury
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 |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06953674 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Louisville, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.