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

External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial

This study is testing if using a special drainage method can safely lower brain pressure in people with severe traumatic brain injuries while they receive standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Brain Trauma Foundation (other)
• Locations: 6 sites (Gainesville, Florida and 5 other locations)
• Trial ID: NCT05889650 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a Glasgow Coma Scale score of 3-8 and specific imaging findings indicating suitability for ELD.

Not a fit: Patients with a Glasgow Coma Scale score greater than 8 or significant midline shift on CT may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new method to safely lower intracranial pressure in patients with severe TBI, potentially improving outcomes.

How similar studies have performed: Previous non-randomized studies have shown that external lumbar drainage can effectively lower intracranial pressure, suggesting potential success for this approach.

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 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 this trial is running

Gainesville, Florida and 5 other locations

• 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

Conditions: Severe Traumatic Brain Injury, Intracranial Hypertension, Traumatic brain injury, intracranial pressure, intracranial hypertension, lumbar drainage