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RECRUITINGPhase 3INTERVENTIONAL

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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-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.

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.

Locations (1)

University of Louisville Hospital
Louisville, Kentucky, United States