Saline vs Balanced Crystalloid for Traumatic Brain Injury

(FLUID-TBI Trial)

Overseen By Mechelle Kaufman, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Louisville

Disqualifiers: Severe visceral trauma, Non-survivable brain injury, Emergent visceral surgery, Ruptured vascular malformation, Transferred patients

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of fluids—saline and balanced crystalloids—to determine which is more effective for treating moderate or severe Traumatic Brain Injury (TBI). Participants will receive one of these fluids through an IV in the hospital, and researchers will monitor their recovery. The goal is to identify which fluid improves outcomes for TBI patients. Candidates for this trial include those with a head injury involving a skull fracture or bleeding who received emergency room treatment. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment for TBI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both balanced crystalloids and normal saline are commonly used fluids for treating patients with traumatic brain injury (TBI), but they may affect patients differently. Some studies suggest that balanced crystalloids might lead to worse outcomes for TBI patients compared to saline. Specifically, patients receiving balanced crystalloids were more likely to be transferred to another medical facility or pass away. Conversely, other research indicates that balanced crystalloids may reduce the risk of death in critically ill patients without TBI.

Normal saline is widely used and generally well-tolerated in medical settings. Both treatments are administered under careful medical supervision, with healthcare teams monitoring for any side effects. Discuss any concerns with the trial team or your doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring the use of balanced crystalloid solutions for traumatic brain injury because these fluids may more closely match the body's natural electrolyte balance compared to normal saline. Most treatments for traumatic brain injury involve using normal saline, which can sometimes lead to complications like acidosis due to its high chloride content. Balanced crystalloids, on the other hand, are designed to avoid such issues by mimicking the body's plasma composition more closely. This could potentially improve patient outcomes by reducing the risk of metabolic imbalances during treatment.

What evidence suggests that this trial's treatments could be effective for Traumatic Brain Injury?

This trial will compare balanced crystalloids and normal saline for patients with traumatic brain injury (TBI). Research has shown that balanced crystalloids can benefit some very sick adults. However, studies have found that for TBI patients, balanced solutions might be linked to higher in-hospital death rates. While balanced crystalloids can be useful in some cases, they might not be the best choice for TBI patients. In contrast, normal saline is commonly used in hospitals and has been widely administered for TBI without the risks associated with balanced solutions. Overall, evidence suggests that normal saline might be a safer option for those with TBI. ^{1 2 4 5 6}

Who Is on the Research Team?

Akshitkumar Mistry, MD

Principal Investigator

Assistant Professor Term

Are You a Good Fit for This Trial?

This trial is for trauma patients who arrive at the Emergency Room with a moderate or severe brain injury, indicated by a Glasgow Coma Scale score of 12 or less and head CT showing skull fractures or hemorrhages larger than 1cm. The cause must be due to trauma.

Inclusion Criteria

I am a trauma patient currently receiving initial care in the Emergency Room.

My consciousness level is significantly impaired.

I have a skull fracture or brain bleed larger than 1cm from an injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous fluids, either saline or balanced crystalloid, with vital signs and laboratory values monitored

2 weeks

Daily monitoring during hospitalization

Follow-up

Participants are monitored for neurological outcomes and disability assessment at 6 months post-injury

6 months

1 visit (in-person or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Balanced Crystalloid
• Normal Saline (0.9% NaCl)

Trial Overview The study is testing whether saline (normal salt solution) or balanced crystalloid fluids are more effective when given intravenously to patients with traumatic brain injuries. It will track vital signs, treatments, and other medical data for up to 14 days in hospital and assess disability six months post-injury.

How Is the Trial Designed?

Group I: Normal Saline Experimental Treatment 1 Intervention

normal saline (0.9% sodium chloride) administered intravenously

Group II: Isotonic Crystalloid Active Control 1 Intervention

balanced crystalloid intravenous fluid therapy

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Kentucky Spinal Cord and Head Injury Research Board

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9422787/

Balanced Crystalloid versus Saline in Adults with ... Balanced crystalloids may improve outcomes compared with saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen cerebral ...

2. liebertpub.com liebertpub.com/doi/abs/10.1089/neu.2021.0465

Balanced Crystalloid versus Saline in Adults with ... Balanced crystalloids may improve outcomes compared with saline for some critically ill adults. Lower tonicity of balanced crystalloids could worsen ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213260023004174

Balanced crystalloids versus saline for critically ill patients ... In patients with traumatic brain injury, using balanced solutions was associated with increased in-hospital mortality. Funding. HCor (Brazil) and The George ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06953674

Saline Versus Balanced Crystalloid in Traumatic Brain Injury 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39832223/

Effect of Treatment With Balanced Crystalloids Versus ... In comparison to normal saline, balanced solutions were associated with a reduction in mortality in critical care patients without TBI.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1711584

Balanced Crystalloids versus Saline in Critically Ill Adults Among critically ill adults, the use of balanced crystalloids for intravenous fluid administration resulted in a lower rate of the composite ...