RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

External Lumbar drainage

ELD @ 15 or 20mmHg based on intervention arm with maximum of 10ml/hour drainage

Locations (5)

University of Florida

Gainesville, Florida, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

University of Texas

San Antonio, Texas, United States