Recruiting

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

ClinicalTrials.gov IDNCT05889650

PhaseNA

Enrollment30

SponsorBrain Trauma Foundation

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Severe Traumatic Brain Injury, Intracranial Hypertension

About this study

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.

Interventions

Procedure: External Lumbar drainage — ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage

Primary outcomes

Safety of ELD in selected Severe TBI patients (10 days)
Feasibility of ELD in selected Severe TBI patients (10 days)

Eligibility information

Inclusion Criteria: 1. 18-65 years age 2. Glasgow Coma Scale (GCS) 3-8 3. Pupils symmetric and bilaterally reactive 4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT 5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT 6. First randomization and intervention may be commenced within 24 hours of injury 7. ELD safety score ≥5 Exclusion Criteria: 1. GCS \>8 2. Cisterns on CT completely effaced 3. Midline shift on CT \>5mm 4. GCS 3 with dilated and fixed pupils 5. Uncal or tonsillar herniation on admission or post-operative brain CT 6. Temporal lobe contusions with effaced ipsilateral cisterns 7. Penetrating TBI 8. Primary hemicraniectomy 9. Pregnancy 10. Prisoners 11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care 12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year 13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity. 14. posterior fossa hemorrhage

Study locations

University of Florida, Gainesville, Florida 32610 United States
Kansas University Medical Center, Kansas City, Kansas 66160 United States
University of Texas Southwestern Medical Center, Dallas, Texas 75390 United States
Brooke Army Medical Center, Fort Sam Houston, Texas 78234 United States
University of Houston Medical Center, Houston, Texas 77030 United States
University of Texas, San Antonio, Texas 78249 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.