Saline Versus Balanced Crystalloid in Traumatic Brain Injury
This study is looking at whether Normal Saline (0.9% NaCl) or a balanced crystalloid (types of intravenous fluids) works better for patients with moderate to severe traumatic brain injury (TBI). Doctors want to see if one fluid leads to better recovery. You might be able to join if you are an adult trauma patient with a Glasgow Coma Scale (a measure of consciousness) of 12 or less, and a head CT scan showing skull fractures or bleeding. The study will measure your neurological outcomes (how well your brain recovers) six months after your injury to see which fluid is more helpful. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 600 participants. It compares two different intravenous fluids: Normal Saline and a balanced crystalloid.
- What's involved
- You will receive either saline or balanced fluid through your veins. Medical information will be collected from your records for up to 14 days, and your disability will be assessed during a follow-up doctor's visit six months later.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will have their neurological outcomes assessed at 6 months post injury.
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Saline Versus Balanced Crystalloid in Traumatic Brain Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Akshitkumar Mistry, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor Term
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Neurological Outcomes6 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.