External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial

Launched by BRAIN TRAUMA FOUNDATION · Jun 1, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a procedure called external lumbar drainage (ELD) to see if it is safe and helpful for patients with severe traumatic brain injury (TBI) who also have increased pressure in the brain (intracranial hypertension). The researchers want to find out if using ELD can safely reduce this pressure without causing any serious problems, such as worsening neurological conditions or brain herniation, which is when part of the brain is pushed out of its normal position.

To be eligible for this study, participants must be between 18 and 65 years old with a Glasgow Coma Scale (GCS) score between 3 and 8, which means they have a severe level of consciousness impairment. They must also have certain brain imaging results showing specific conditions. All participants will receive standard medical care, and those in the study group will also have the ELD procedure to help drain excess fluid from the brain. The trial is currently recruiting participants, and it's important to know that there are specific criteria that exclude some patients, such as those with certain brain injuries or conditions that make ELD risky.

Gender

ALL

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
• • 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.