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Saline Versus Balanced Crystalloid in Traumatic Brain Injury

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Louisville
NCT06953674 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Normal Saline (0.9% NaCl)
  • balanced crystalloid
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Where

1 site
University of Louisville Hospital
Louisville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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