NCT05889650Recruiting
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 May 2023
- Start date
- 24 Jun 2024
- Primary completion date
- 15 Jun 2028
- Lead sponsor
- Brain Trauma Foundation
- Diseases
- High blood pressure
- NCT number
- NCT05889650
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 24 Jun 2024 to the primary completion date, 15 Jun 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
Other illness
- Pre-existing conditions affecting functional status or life expectancy to less than 1 year
- posterior fossa hemorrhage
Other
- GCS \>8
- Cisterns on CT completely effaced
- Midline shift on CT \>5mm
- GCS 3 with dilated and fixed pupils
- Uncal or tonsillar herniation on admission or post-operative brain CT
- Temporal lobe contusions with effaced ipsilateral cisterns
- Penetrating TBI
- Primary hemicraniectomy
- Pregnancy
- Prisoners
- Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Brooke Army Medical Center Coordinator of this site? Confirm its status | Fort Sam Houston | United States | Recruiting |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Recruiting |
| University of Houston Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Kansas University Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.