Status:
RECRUITING
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Kentucky Spinal Cord and Head Injury Research Board
Conditions:
Traumatic Brain Injury (TBI) Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. Thi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06953674
Start Date
June 1 2025
End Date
September 1 2029
Last Update
August 17 2025
Active Locations (1)
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1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202