Traumatic Brain Injury (TBI) PatientsPhase 3FLUID-TBINCT06953674
Saline Versus Balanced Crystalloid in Traumatic Brain Injury
A Phase 3 study testing Normal Saline (0.9% NaCl) and balanced crystalloid in people with Traumatic Brain Injury (TBI) Patients, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- What is being tested?
- Normal Saline (0.9% NaCl) and balanced crystalloid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Akshitkumar Mistry, M.D. contact
United States1 site, 1 recruiting
- Recruiting
University of Louisville Hospital
Louisville, Kentucky, 40202
Mechelle Kaufman, BSN, 502-852-5992, mechelle.kaufman@louisville.edu
Akshitkumar a.mistry@uoflhealth.org, M.D.
About this study
Official title: Saline vs. 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 improved outcomes in TBI patients.
Participants will
- be given fluids through the veins, either saline or balanced fluid will be given.
- 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.
- 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.
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Being tested
- Normal Saline (0.9% NaCl), balanced crystalloid
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline (0.9% NaCl)Drug
For the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
balanced crystalloidDrug
For the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Experimental | normal saline (0.9% sodium chloride) administered intravenously Receives: Drug: Normal Saline (0.9% NaCl) |
| Isotonic Crystalloid | Active comparator | balanced crystalloid intravenous fluid therapy Receives: Drug: balanced crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Outcomes
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 TBI patients.
The 8-point ordinal GOSE scale for the primary efficacy assessment will be dichotomized into favorable (GOSE score 4-8) and unfavorable (GOSE 1-3) outcomes. The primary analysis model will be a logistic regression model where the outcome of interest is the dichotomized GOS-E evaluated at 6 months to reflect favorable and unfavorable outcomes. The covariate of interest is a randomization assignment.
Measured: 6 months post injury
Secondary outcomes (1)
Inpatient mortality
We will assess the inpatient mortality of the participants. We will note the time from admission to death or discharge.
The secondary outcome (inpatient mortality) will be analyzed using two approaches. The primary analysis model will be a logistic regression model where the outcome of interest is the vitality status (alive or dead) at discharge. The covariate of interest is a randomization assignment. The secondary analysis will be a time-to-death analysis comparing the survival curves between the two randomized groups using a log-rank test.
Measured: randomization to hospital discharge typically 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Jun 2025
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Kentucky Spinal Cord and Head Injury Research Board
- Responsible party
- Principal investigator, Akshitkumar MIstry, University of Louisville
- Investigators
- Akshitkumar Mistry, MD, Principal investigator, Assistant Professor Term
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953674
- Sponsor's protocol ID
- 24.0224
- Acronym
- FLUID-TBI
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Timeframe for sharing undecided at this early stage
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saline vs. Balanced Crystalloid in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06953674
- Acronym / sponsor ID
- FLUID-TBI / 24.0224
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Kentucky Spinal Cord and Head Injury Research Board
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- be given fluids through the veins, either saline or balanced fluid will be given.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Drug: Normal Saline (0.9% NaCl)normal saline (0.9% sodium chloride) administered intravenously |
| Isotonic Crystalloid | Active comparator | Drug: balanced crystalloidbalanced crystalloid intravenous fluid therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline (0.9% NaCl)For the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions. | Drug | Normal Saline |
| balanced crystalloidFor the primary purpose of fluid therapy or resuscitation in the emergency room and during hospitalization. The interventions will be administered intravenously whenever isotonic intravenous fluid administration is ordered by the treating provider for fluid resuscitation and/or maintenance in the emergency room and during inpatient hospitalization. Assignment to the intervention arm will be adhered to from enrollment to discharge. The total volume, rate, initiation, cessation, and co-interventions will be left to the discretion of the treating provider. Adherence will be ensured by dual interventions at the level of pharmacy IV fluid supply and physician order. The fluids will be physically administered according to the standard intravenous procedures and those outlined in the manufacturer's instructions. | Drug | Isotonic Crystalloid |
Primary outcome
Neurological Outcomes
Time frame: 6 months post injury
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 TBI patients. The 8-point ordinal GOSE scale for the primary efficacy assessment will be dichotomized into favorable (GOSE score 4-8) and unfavorable (GOSE 1-3) outcomes. The primary analysis model will be a logistic regression model where the outcome of interest is the dichotomized GOS-E evaluated at 6 months to reflect favorable and unfavorable outcomes. The covariate of interest is a randomization assignment.
1 secondary outcome
Inpatient mortality
Time frame: randomization to hospital discharge typically 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided. Timeframe for sharing undecided at this early stage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akshitkumar Mistry, M.D. contact
Akshitkumar Mistry, MD principal investigator
Assistant Professor Term
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline (0.9% NaCl) and balanced crystalloid in people with Traumatic Brain Injury (TBI) Patients, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mechelle Kaufman, BSN, RN (502-588-2329, mechelle.kaufman@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological Outcomes (time frame: 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.