Saline Versus Balanced Crystalloid in Traumatic Brain Injury
Recruiting
Phase 3
Interventional Study
Traumatic Brain Injury (TBI) Patients
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 600 (estimated)
- Sponsor
- University of Louisville · Other
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About This Trial
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 …
Trial Locations
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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 mortal…
Contacts