External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

What this Trial Is About

Researchers are evaluating the safety and feasibility of external lumbar drainage (ELD) as an additional treatment to reduce brain pressure in patients with severe traumatic brain injury (TBI). This phase 1 randomized controlled trial compares usual care alone to usual care plus ELD in patients who have specific brain imaging findings, such as patent basal cisterns and a midline shift less than 5mm. The study aims to determine whether ELD can be safely performed without increasing risks like neurological worsening or brain herniation. Participants will be randomly assigned to one of three groups: early ELD at 15 mmHg if intracranial pressure (ICP) is not raised, ELD at 20 mmHg if ICP remains above 20 mmHg despite other treatments, or usual treatment alone following established guidelines. The ELD procedure involves controlled drainage of cerebrospinal fluid with a maximum volume of 10 ml per hour. All patients receive standard care, with the addition of ELD in the intervention groups, and no treatments are withheld. During the study, participants will undergo regular neurological monitoring including automated pupillometry every hour and Glasgow Coma Scale assessments. Safety monitoring is intensified around ELD placement with pupillometry every 15 minutes for the first hour. Researchers will measure the safety and feasibility of ELD over 10 days and investigate how well pupillometry predicts safety. The trial includes follow-up for neurological worsening events, intracranial pressure changes, and adverse events, with safety oversight by an expert board.

External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial