NCT06953674 Saline Versus Balanced Crystalloid in Traumatic Brain Injury
| NCT ID | NCT06953674 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Louisville |
| Condition | Traumatic Brain Injury (TBI) Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2025-06-01 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Akshitkumar Mistry, MD
PRINCIPAL INVESTIGATOR
Assistant Professor Term
Frequently Asked Questions
Who can join the NCT06953674 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury (TBI) Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06953674 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT06953674 currently recruiting?
Yes, NCT06953674 is actively recruiting participants. Contact the research team at mechelle.kaufman@louisville.edu for enrollment information.
Where is the NCT06953674 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06953674 clinical trial?
NCT06953674 is sponsored by University of Louisville. The principal investigator is Akshitkumar Mistry, MD at Assistant Professor Term. The trial plans to enroll 600 participants.