External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial (NCT05889650) | Clinical Trial Compass
RecruitingNot Applicable
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
United States30 participantsStarted 2024-06-24
Plain-language summary
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 participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Safety of ELD in selected Severe TBI patients
Timeframe: 10 days
2
Feasibility of ELD in selected Severe TBI patients