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NCT05889650 · ClinicalTrials.gov registry record · NA
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
A NA study of Severe Traumatic Brain Injury and Intracranial Hypertension, sponsored by Brain Trauma Foundation.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 5
- Study locations
NCT05889650: Recruiting NA study of Severe Traumatic Brain Injury and Intracranial Hypertension, sponsored by Brain Trauma Foundation.
NCT05889650 is a NA study of Severe Traumatic Brain Injury and Intracranial Hypertension that is actively recruiting participants, run by Brain Trauma Foundation. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05889650, a NA study of Severe Traumatic Brain Injury and Intracranial Hypertension, is actively recruiting participants, sponsored by Brain Trauma Foundation.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Rate of occurrence of herniation events or death in 3 arms
Conditions Studied
Interventions
- PROCEDURE External Lumbar drainage
Study Locations (5)
Texas
- University of Texas Southwestern Medical Center - Dallas
- Brooke Army Medical Center - Fort Sam Houston
- University of Texas - San Antonio
Florida
- University of Florida - Gainesville
Kansas
- Kansas University Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-06-24 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What NCT05889650 shows while recruiting
NCT05889650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Severe Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which External Lumbar drainage is the first listed.
NCT05889650 lists 5 locations in 3 states (Texas, Florida, Kansas).
Frequently Asked Questions
What is clinical trial NCT05889650 about?
NCT05889650 is a clinical study titled "External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial". 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 ...
What is the current status of trial NCT05889650?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-06-24. Estimated completion is 2027-06-30.
What conditions does trial NCT05889650 study?
This clinical trial studies the following conditions: Severe Traumatic Brain Injury, Intracranial Hypertension.
What interventions are being tested in trial NCT05889650?
The interventions under investigation include: External Lumbar drainage (PROCEDURE).
Who is sponsoring clinical trial NCT05889650?
This trial is sponsored by Brain Trauma Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05889650 being conducted?
This trial has 5 study locations across Florida, Kansas, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05889650's enrollment target sits among peer trials
30 1594th of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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