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

RecruitingNAAges 18 Years - 65 YearsAllBrain Trauma Foundation
NCT05889650 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 18-65 years age 2. Glasgow Coma Scale (GCS) 3-8 3. Pupils symmetric and bilaterally reactive 4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT 5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT 6. First randomization and intervention may be commenced within 24 hours of injury 7. ELD safety score ≥5 Exclusion Criteria: 1. GCS \>8 2. Cisterns on CT completely effaced 3. Midline shift on CT \>5mm 4. GCS 3 with dilated and fixed pupils 5. Uncal or tonsillar herniation on admission or post-operative brain CT 6. Temporal lobe contusions with effaced ipsilateral cisterns 7. Penetrating TBI 8. Primary hemicraniectomy 9. Pregnancy 10. Prisoners 11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care 12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year 13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity. 14. posterior fossa hemorrhage
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What it tests

  • External Lumbar drainage
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Where

6 sites
University of Florida
Gainesville, United States
Kansas University Medical Center
Kansas City, United States
University of Texas Southwestern Medical Center
Dallas, United States
Brooke Army Medical Center
Fort Sam Houston, United States
University of Houston Medical Center
Houston, United States
University of Texas
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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