RecruitingNot ApplicableNCT05889650

External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

Sponsor

Brain Trauma Foundation

Enrollment

30 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Severe Traumatic Brain Injury Intracranial Hypertension

Summary

The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial tests whether draining fluid from the lower spine can safely reduce dangerous pressure buildup in the brain after a severe traumatic brain injury (TBI). **You may be eligible if...** - You are between 18 and 65 years old - You have suffered a severe brain injury (low Glasgow Coma Scale score of 3–8, meaning deeply unconscious) - Your pupils respond normally to light - Brain scans show limited brain shift and open fluid pathways around the brain **You may NOT be eligible if...** - You are outside the 18–65 age range - Your brain scans show significant brain shift or blocked fluid spaces - Your pupils are unresponsive or mismatched Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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