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NCT06953674 | NOT YET RECRUITING | Traumatic Brain Injury (TBI) Patients

Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Sponsor:

University of Louisville

Information provided by (Responsible Party):

Akshkumar Mistry

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.

Condition or disease

Traumatic Brain Injury (TBI) Patients

Intervention/treatment

Normal Saline (0.9% NaCl)

balanced crystalloid

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 600 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Saline vs. Balanced Crystalloid in Traumatic Brain Injury
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2029-06
Estimated Study Completion Date : 2029-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Location Details

NCT06953674

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How to Participate

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Locations

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