At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Glasgow Coma Scale 3-8
- ✓Pupils symmetric and bilaterally reactive
- ✓Midline shift ≤5mm on admission or post-operative brain CT
- ✕GCS >8
- ✕Completely effaced cisterns on CT
- ✕Midline shift >5mm on CT
- ✕GCS 3 with dilated and fixed pupils
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial
In Brief
A clinical study evaluating External Lumbar drainage for Severe Traumatic Brain Injury and Intracranial Hypertension. Currently recruiting, targeting 30 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage