External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension Phase 1 Randomized Clinical Trial: Scientific Rationale and Methodology: An MTBI2 Study

A multitude of clinical trials to advance or discover new treatments of severe TBI have remained unfruitful. Recent understanding of the glymphatic system in the brain is suggestive that extraventricular CSF drainage may be very useful in reducing ICP. The natural avenue for this is through ELD. To avoid past mistakes by jumping into an advanced stage trial, we intend to conduct a phase 1 safety and feasibility trial to identify 'select' patients in whom ELD may be performed safely and may serve as a significant change of therapeutic approach to such patients with traumatic intracranial hypertension.