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Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Recruiting
18 years and older
All
Phase 3

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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.

Eligibility

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

Study details
    Traumatic Brain Injury (TBI) Patients

NCT06953674

University of Louisville

11 September 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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