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

Qualifiers

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

Treatments tested in this trial

  • External Lumbar drainage

Treatment groups

30 Participants
are divided into 3 treatment groups

Locations

6
University of Florida32610, GainesvilleFlorida, United States
Kansas University Medical Center66160, Kansas CityKansas, United States
University of Texas Southwestern Medical Center75390, DallasTexas, United States
Brooke Army Medical Center78234, Fort Sam HoustonTexas, United States

Sponsors and collaborators

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