Actively Recruiting
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
Led by Brain Trauma Foundation · Updated on 2026-04-22
30
Participants Needed
6
Research Sites
209 weeks
Total Duration
On this page
Sponsors
B
Brain Trauma Foundation
Lead Sponsor
U
Uniformed Services University of the Health Sciences
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Glasgow Coma Scale (GCS) score between 3 and 8
- Pupils symmetric and reactive in both eyes
- Midline brain shift of 5 mm or less on brain CT scan
- Patent (complete or partial) quadrigeminal cisterns on brain CT scan
- Randomization and intervention can start within 24 hours of injury
- ELD safety score of 5 or higher
You will not qualify if you...
- Glasgow Coma Scale (GCS) score greater than 8
- Completely effaced (closed) basal cisterns on brain CT
- Midline brain shift greater than 5 mm on CT
- GCS score of 3 with dilated and fixed pupils
- Evidence of uncal or tonsillar brain herniation on CT
- Temporal lobe contusions with effaced ipsilateral cisterns
- Penetrating traumatic brain injury
- Previous hemicraniectomy (skull removal surgery)
- Pregnancy
- Prisoner status
- Patients lacking capacity to consent or with advanced directives to forego aggressive care
- Pre-existing conditions lowering functional status or life expectancy to less than 1 year
- Contraindications for ELD: coagulopathy, use of blood thinners, low platelets (<50,000), or severe spinal deformity
- Posterior fossa brain hemorrhage
AI-Screening
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Trial Site Locations
Total: 6 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
4
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Actively Recruiting
5
University of Houston Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
6
University of Texas
San Antonio, Texas, United States, 78249
Actively Recruiting
Research Team
C
Carlos Morales, MPH
CONTACT
H
Halinder S Mangat, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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