Saline Versus Balanced Crystalloid in Traumatic Brain Injury

NCT ID: NCT06953674

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2029-09-30

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. 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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Normal Saline

normal saline (0.9% sodium chloride) administered intravenously

Group Type: EXPERIMENTAL

Normal Saline (0.9% NaCl)

Intervention Type: 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

balanced crystalloid intravenous fluid therapy

Group Type: ACTIVE_COMPARATOR

balanced crystalloid

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kentucky Spinal Cord and Head Injury Research Board

UNKNOWN

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Akshitkumar MIstry

Assistant Professor Term

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Akshitkumar Mistry, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor Term

Locations

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mechelle Kaufman, BSN, RN

Role: CONTACT

mechelle.kaufman@louisville.edu

502-588-2329

Akshitkumar Mistry, M.D.

Role: CONTACT

a.mistry@uoflhealth.org

Facility Contacts

Mechelle Kaufman, BSN

Role: primary

mechelle.kaufman@louisville.edu

502-852-5992

Akshitkumar a.mistry@uoflhealth.org, M.D.

Role: backup

Other Identifiers

24.0224

Identifier Type: -

Identifier Source: org_study_id