External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension Phase 1 Randomized Clinical Trial: Scientific Rationale and Methodology: An MTBI2 Study.
Academic Article
Overview
abstract
BACKGROUND AND OBJECTIVES: There has been renewed interest in the use of external lumbar drainage (ELD) of cerebrospinal fluid (CSF) to reduce intracranial pressure after traumatic brain injury (TBI). Although the evidence is retrospective and thus confounded by selection bias, it is critical that a phase 1 trial systematically identify "select" patients who would gain benefit of intracranial pressure (ICP) reduction from lumbar drainage. The aim of this study is to evaluate safety and feasibility of controlled CSF ELD in reducing ICP burden and improving outcomes of select severe TBI patients. METHODS: The study will include 30 severe TBI patients with a Glasgow Coma Scale score ≤9 who will be randomized to usual treatment, usual treatment plus early ELD placement if initial ICP ≤20 mm Hg, or late ELD if ICP ≥20 mm Hg as first intervention in tier 2 of Seattle International Brain Injury Consensus Consortium protocol. EXPECTED OUTCOMES: It is expected that the incidence of severe neurological worsening events as per Seattle International Brain Injury Consensus Consortium will not be different between the control and intervention groups. DISCUSSION: 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.
