NCT05889650 External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
| NCT ID | NCT05889650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brain Trauma Foundation |
| Condition | Severe Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2028-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-06-24 with a primary completion date of 2028-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Halinder S Mangat, MD MSc
PRINCIPAL INVESTIGATOR
Brain Trauma Foundation; Kansas University Medical Center Research Institute
Frequently Asked Questions
Who can join the NCT05889650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Severe Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05889650 currently recruiting?
Yes, NCT05889650 is actively recruiting participants. Contact the research team at carlos.morales.ctr@usuhs.edu for enrollment information.
Where is the NCT05889650 trial being conducted?
This trial is being conducted at Gainesville, United States, Kansas City, United States, Dallas, United States, Fort Sam Houston, United States and 2 additional locations.
Who is sponsoring the NCT05889650 clinical trial?
NCT05889650 is sponsored by Brain Trauma Foundation. The principal investigator is Halinder S Mangat, MD MSc at Brain Trauma Foundation; Kansas University Medical Center Research Institute. The trial plans to enroll 30 participants.