External Lumbar Drainage for Severe Traumatic Brain Injury
External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
Recruiting
N/A
Interventional Study
Severe Traumatic Brain Injury
Intracranial Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- Brain Trauma Foundation · Other
Who this trial is looking for
This trial is looking for adults with severe traumatic brain injury. Participants will receive regular care and an additional treatment to help drain fluid from the spine.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 65 years old.
- I have a Glasgow Coma Scale score between 3 and 8.
- My pupils respond normally.
- I have a midline shift of 5 mm or less on my brain scan.
- My brain scans show open quadrigeminal cisterns.
- My treatment can start within 24 hours of my injury.
- I have a safety score of 5 or higher for the drainage procedure.
You may not be able to join if
- My Glasgow Coma Scale score is above 8.
- My brain scans show completely effaced cisterns.
- I have a midline shift of more than 5 mm.
- I have dilated and non-reactive pupils with a score of 3.
- I have signs of herniation on my brain scans.
- I have penetrating brain injury.
- I am pregnant.
- I have a bleeding disorder or severe spinal deformity.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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About This 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 severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm …
Trial Locations
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Eligibility Criteria
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 br…
Contacts