Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Normal Saline (0.9% NaCl)
- balanced crystalloid
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Louisville
Lead sponsor
Kentucky Spinal Cord and Head Injury Research Board
Collaborator
Source ClinicalTrials.gov