Testing spinal fluid drainage to reduce brain swelling after severe head injury

Plain-English translation of NCT05889650 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated July 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This is a safety and feasibility study testing external lumbar drainage (ELD)—a procedure where fluid is drained from around the spinal cord—to help reduce dangerous pressure buildup in the brain after severe traumatic brain injury. The treatment is given alongside all standard care. Researchers want to confirm that this procedure is safe and effective for patients whose brain swelling cannot be controlled by usual treatments alone.

After severe head injuries, the brain swells and pressure builds up inside the skull, which can cause further injury and disability or death. While some research shows external lumbar drainage works well at reducing this pressure quickly and safely, many doctors haven't used it because of old concerns about safety. This trial will provide solid evidence about whether this treatment is truly safe and should be used more widely.

Do you qualify?

You likely qualify if…

you are between 18 and 65 years old
you have a severe traumatic brain injury with very low consciousness scores (Glasgow Coma Scale 3–8)
your pupils are normal and reactive in both eyes
the swelling and shifting of your brain on CT scan is mild enough to allow safe drainage
you can start the treatment within 24 hours of your injury

You likely don't qualify if…

you have bleeding in the back of your brain (posterior fossa hemorrhage)
your brain tissue has herniated or is severely herniated on imaging
you have a blood clotting disorder or are taking blood thinners that cannot be stopped
you have severe curvature or deformity of your spine that would prevent safe placement of the drain
you have a pre-existing condition that would affect your ability to recover or survive beyond one year

What participation looks like

If you are enrolled, you will be randomly assigned to receive either standard brain injury treatment alone, or standard treatment plus early or late external lumbar drainage—a thin tube placed in your lower spine to gently drain cerebrospinal fluid and reduce brain pressure. You will receive all usual medical care for severe brain injury; the drainage procedure is added to what you're already getting. The trial team will monitor your condition closely with imaging, pressure measurements, and clinical exams throughout your hospital stay and recovery.

AI-generated summary from trial data · Jul 7, 2026 · Not medical advice

Testing spinal fluid drainage to reduce brain swelling after severe head injury

What is this trial?

Do you qualify?

What participation looks like

Trial locations