Saline Versus Balanced Crystalloid in Traumatic Brain Injury

NCT06953674 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 24.0224
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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. This trial will determine whether the use of saline or balanced crystalloids is associated with improved outcomes in TBI patients. Participants will

1. 1.be given fluids through the veins, either saline or balanced fluid will be given.
2. 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. 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.

Conditions

Traumatic Brain Injury (TBI) Patients

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months post injury

Secondary Outcomes (1)

• Inpatient mortality

  randomization to hospital discharge typically 2 weeks.

Other Outcomes (1)

• To compare delayed interventions to treat Intracranial pressure (ICP).

  randomization to hospital discharge, typically 2 weeks.

Study Arms (2)

Normal Saline

EXPERIMENTAL

normal saline (0.9% sodium chloride) administered intravenously

Drug: Normal Saline (0.9% NaCl)

Isotonic Crystalloid

ACTIVE COMPARATOR

balanced crystalloid intravenous fluid therapy

Drug: balanced crystalloid

Interventions

Normal Saline (0.9% NaCl) DRUG

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.

Normal Saline

balanced crystalloid DRUG

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.

Isotonic Crystalloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• Kentucky Spinal Cord and Head Injury Research Board: collaborator

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Akshitkumar Mistry, MD

  Assistant Professor Term

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mechelle Kaufman, BSN, RN

CONTACT

502-588-2329; mechelle.kaufman@louisville.edu

Akshitkumar Mistry, M.D.

CONTACT

a.mistry@uoflhealth.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Term

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 1, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)