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

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

Who can join

Ages 18 to 65 · All sexes

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

About the study

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.

What is being tested

• External Lumbar drainage (procedure)

Sponsor: Brain Trauma Foundation · Participants: 30 · Started: Jun 24, 2024

Contact the study team

• Carlos Morales, MPH · Phone: 240-6536638
• Halinder S Mangat, MD, MSc · Phone: 913-5886970

Official record on ClinicalTrials.gov — NCT05889650

Locations in the U.S.

Conditions

• Traumatic Brain Injury

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.