About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
18-65 years age
Glasgow Coma Scale (GCS) 3-8
Pupils symmetric and bilaterally reactive
Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
Disqualifiers
GCS >8
Cisterns on CT completely effaced
Midline shift on CT >5mm
GCS 3 with dilated and fixed pupils
Trial design
Sequential
Treatments tested in this trial
External Lumbar drainage
Procedure/SurgeryELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage
Treatment groups
Trial outcomes
Primary outcomes
Safety of ELD in selected Severe TBI patients
Rate of occurrence of herniation events or death in 3 arms
Feasibility of ELD in selected Severe TBI patients
Proportion of patients able to undergo treatment as per randomised arm
Secondary outcomes
Reduction in ICP burden using ELD in selected severe TBI patients
Total number of hours with ICP\>20mmHg
Utility of automated pupillometry to predict safety of ELD
worsening of Pupillometry based reactivity index in 6 hours preceding herniation events with occurrence of such events
Sponsors and contacts
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Brain Trauma Foundation
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
University of Kansas
Collaborator
The Cleveland Clinic
Collaborator
Weill Medical College of Cornell University
Collaborator