Using external lumbar drainage to lower brain pressure in severe traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 clinical trial aims to evaluate the safety and feasibility of external lumbar drainage (ELD) in patients with severe traumatic brain injury (TBI) who have specific radiological criteria. Participants will receive standard care along with ELD for cerebrospinal fluid drainage, and the study will compare outcomes between those receiving ELD and those receiving only standard treatment. The primary focus is to assess whether ELD can effectively reduce intracranial pressure without increasing the risk of neurological deterioration or cerebral herniation.

Why it matters

Who can join: the full rules

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 brain CT
6. First randomization and intervention may be commenced within 24 hours of injury
7. ELD safety score ≥5

Exclusion Criteria:

1. GCS \>8
2. Cisterns on CT completely effaced
3. Midline shift on CT \>5mm
4. GCS 3 with dilated and fixed pupils
5. Uncal or tonsillar herniation on admission or post-operative brain CT
6. Temporal lobe contusions with effaced ipsilateral cisterns
7. Penetrating TBI
8. Primary hemicraniectomy
9. Pregnancy
10. Prisoners
11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year
13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \<50,000, or severe spinal deformity.
14. posterior fossa hemorrhage

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting
• Kansas University Medical Center
  Kansas City, Kansas, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Brooke Army Medical Center
  Fort Sam Houston, Texas, United States Recruiting
• University of Houston Medical Center
  Houston, Texas, United States Recruiting
• University of Texas
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Halinder S Mangat, MD MSc — Brain Trauma Foundation; Kansas University Medical Center Research Institute
• Study coordinator: Carlos Morales, MPH
• Email: carlos.morales.ctr@usuhs.edu
• Phone: 240-6536638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.