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

Sponsored by Brain Trauma Foundation

About this study

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.

This is a randomized controlled trial to determine the safety and feasibility of external lumbar drainage (ELD) of cerebrospinal fluid (CSF) as an adjunct to existing treatments to lower brain pressure, in select patients suffering severe traumatic brain injury (TBI). This trial is funded by the Department of Defense, Uniformed Services University of Health Sciences, Center for Neuroscience and Regenerative Medicine (CNRM). Following a severe TBI, the brain swells and the pressure in the cranium rises causing further brain injury, The goal of treatment of such patients is to use treatments that lower brain swelling or pressure - directly by removing blood clots or indirectly by trying to lower the volume of contents in the cranium, viz. CSF or blood. Routinely a drain is placed in the sku…

Where this study is enrolling (6)

  • University of Florida

    Gainesville, Florida

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  • Kansas University Medical Center

    Kansas City, Kansas

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  • Brooke Army Medical Center

    Fort Sam Houston, Texas

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  • University of Houston Medical Center

    Houston, Texas

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  • University of Texas Southwestern Medical Center

    Dallas, Texas

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Who can participate

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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Trial data sourced from ClinicalTrials.gov.