RECRUITING

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Saline vs. Balanced Crystalloid in Traumatic Brain Injury

Quick Facts

Study Start:2025-06-01
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06953674

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Trauma patients presenting to the Emergency Room for initial care
  2. * Glasgow Coma Scale ≤ 12
  3. * Head CT with skull fracture(s) and/or hemorrhage(s) (\>1cm in any single dimension) with a reported mechanism of trauma
  1. * Severe visceral trauma dictating mortality (visceral injury severity score \> brain injury severity score)
  2. * Non-survivable brain injury based on the treating physician's judgment
  3. * Emergent visceral operative intervention before complete trauma assessment
  4. * Concern for ruptured intracranial vascular malformation
  5. * Patients who are transferred from another facility

Contacts and Locations

Study Contact

Mechelle Kaufman, BSN, RN
CONTACT
502-588-2329
mechelle.kaufman@louisville.edu
Akshitkumar Mistry, M.D.
CONTACT
a.mistry@uoflhealth.org

Principal Investigator

Akshitkumar Mistry, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor Term

Study Locations (Sites)

University of Louisville Hospital
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Akshitkumar Mistry, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor Term

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01
Study Completion Date2029-09

Study Record Updates

Study Start Date2025-06-01
Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury (TBI) Patients