External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
Recruiting · NCT05889650 · Interventional (participants receive a specific treatment) · Lead sponsor: Brain Trauma Foundation
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
- First randomization and intervention may be commenced within 24 hours of injury
- ELD safety score ≥5
Exclusion criteria
- GCS \>8
- Cisterns on CT completely effaced
- Midline shift on CT \>5mm
- GCS 3 with dilated and fixed pupils
- Uncal or tonsillar herniation on admission or post-operative brain CT
- Temporal lobe contusions with effaced ipsilateral cisterns
- Penetrating TBI
- Primary hemicraniectomy
- Pregnancy
- Prisoners
- Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
- Pre-existing conditions affecting functional status or life expectancy to less than 1 year
- Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
- posterior fossa hemorrhage
Where it is running
6 locations listed across 3 US states.
- University of Florida - Gainesville, Florida, United States
- Kansas University Medical Center - Kansas City, Kansas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Brooke Army Medical Center - Fort Sam Houston, Texas, United States
- University of Houston Medical Center - Houston, Texas, United States
- University of Texas - San Antonio, Texas, United States