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RECRUITINGPhase 3NCT06953674

Saline Versus Balanced Crystalloid in Traumatic Brain Injury

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. Thi...

Lead sponsor: University of Louisville•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Mechelle Kaufman, BSN, RN

CONTACT

502-588-2329 [email protected]

Akshitkumar Mistry, M.D.

CONTACT

[email protected]

Sponsors

Lead Sponsor

University of Louisville

Collaborators

Kentucky Spinal Cord and Head Injury Research Board

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 17, 2025Terms

Trial snapshot

StatusRECRUITING

PhasePHASE3

Enrollment600

Start dateJun 2025

Last updatedAug 17, 2025

Condition

Traumatic Brain Injury (TBI) Patients

Locations shown

University of Louisville Hospital

Louisville, Kentucky

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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