Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Official title

Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Overview

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.

Interventions

• Drug Normal Saline (0.9% NaCl)
  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-interventio
• 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-interventio

Primary outcome measures

• Neurological Outcomes [Time frame: 6 months post injury]

Secondary outcome measures (1)

• Inpatient mortality [Time frame: randomization to hospital discharge typically 2 weeks.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Louisville Hospital — Louisville

Identifiers

NCT: NCT06953674 · 24.0224

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗