External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
Public ClinicalTrials.gov record NCT05889650. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05889650
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2024
- Primary completion
- Jun 14, 2028
- Completion
- Jun 29, 2028
- Last update posted
- Apr 21, 2026
2024 – 2028
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | Recruiting |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | Recruiting |
| University of Houston Medical Center | Houston | Texas | 77030 | Recruiting |
| University of Texas | San Antonio | Texas | 78249 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05889650, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05889650 live on ClinicalTrials.gov.