A Phase 3 interventional study of Normal Saline (0.9% NaCl) and balanced crystalloid in Traumatic Brain Injury (TBI) Patients, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Louisville · Phase 3, Interventional, and Treatment
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
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 600 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of Louisville is the lead sponsor of 291 studies on the registry; 54 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 7 (37%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
normal saline (0.9% sodium chloride) administered intravenously
Drug: Normal Saline (0.9% NaCl)
balanced crystalloid intravenous fluid therapy
Drug: balanced crystalloid
For the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
For the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
Neurological Outcomes
Glasgow Outcome Scale-Extended (GOSE) 8-point scale. Glasgow Outcome Scale has been widely accepted as the standard assessment scale of global outcomes after severe brain injury because it captures well how the injury affects functioning in major areas of life. Using the manual for the GOSE interview, we will conduct our primary efficacy assessment at 6 months after ICU admission in person or over the phone. Outcomes on the GOSE scale do not change past the 6-month mark in moderate and severe TBI patients. The 8-point ordinal GOSE scale for the primary efficacy assessment will be dichotomized into favorable (GOSE score 4-8) and unfavorable (GOSE 1-3) outcomes. The primary analysis model will be a logistic regression model where the outcome of interest is the dichotomized GOS-E evaluated at 6 months to reflect favorable and unfavorable outcomes. The covariate of interest is a randomization assignment.
Time frame: 6 months post injury
Inpatient mortality
We will assess the inpatient mortality of the participants. We will note the time from admission to death or discharge. The secondary outcome (inpatient mortality) will be analyzed using two approaches. The primary analysis model will be a logistic regression model where the outcome of interest is the vitality status (alive or dead) at discharge. The covariate of interest is a randomization assignment. The secondary analysis will be a time-to-death analysis comparing the survival curves between the two randomized groups using a log-rank test.
Time frame: randomization to hospital discharge typically 2 weeks.
To compare delayed interventions to treat Intracranial pressure (ICP).
Surgical or medical ICP-related therapeutic interventions. Events of acute kidney injury, cerebral edema, and in-patient mortality, will be captured.
Time frame: randomization to hospital discharge, typically 2 weeks.
Plan to share: Undecided — Timeframe for sharing undecided at this early stage
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jun 2029, 48 months after the start.
Of 30 phase 3 interventional studies under Brain Injuries, Traumatic, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 69. This study's planned 48 months is close to that.
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