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NCT06953674 · ClinicalTrials.gov registry record · Phase 3
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
A Phase 3 study of Traumatic Brain Injury (TBI) Patients, sponsored by University of Louisville.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 1
- Study location
NCT06953674: Recruiting Phase 3 study of Traumatic Brain Injury (TBI) Patients, sponsored by University of Louisville.
NCT06953674 is a Phase 3 study of Traumatic Brain Injury (TBI) Patients that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 600 participants, above the 46-participant average among 4 other Traumatic Brain Injury (TBI) Patients trials with a reported enrollment target (1204% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953674, a Phase 3 study of Traumatic Brain Injury (TBI) Patients, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Glasgow Outcome Scale-Extended (GOSE) 8-point scale. Glasgow Outcome Scale has been widely accepted as the standard assessment scale of global outcomes after severe brain injury because it captures well how the injury affects functioning in major areas of life. Using the manual for the GOSE interview, we will conduct our primary efficacy assessment at 6 months after ICU admission in person or over the phone. Outcomes on the GOSE scale do not change past the 6-month mark in moderate and severe TB
Conditions Studied
Interventions
- DRUG Normal Saline (0.9% NaCl)
- DRUG balanced crystalloid
Study Locations (1)
Kentucky
- University of Louisville Hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-06-01 |
| Est. Completion | 2029-09 |
| Phase | Phase 3 |
What NCT06953674 shows while recruiting
NCT06953674 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 4 other Traumatic Brain Injury (TBI) Patients trials with a reported enrollment target (1204% higher).
The record links to 1 condition, with Traumatic Brain Injury (TBI) Patients appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline (0.9% NaCl) is the first listed.
NCT06953674 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT06953674 about?
NCT06953674 is a clinical study titled "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. This trial will determine whether the use of saline or balanced crystalloids is associated with improve...
What is the current status of trial NCT06953674?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-06-01. Estimated completion is 2029-09.
What conditions does trial NCT06953674 study?
This clinical trial studies the following conditions: Traumatic Brain Injury (TBI) Patients.
What interventions are being tested in trial NCT06953674?
The interventions under investigation include: Normal Saline (0.9% NaCl) (DRUG), balanced crystalloid (DRUG).
Who is sponsoring clinical trial NCT06953674?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06953674 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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