Name: External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension (ELASTIC): A Phase 1 Randomized, Allocation-Concealed, Open-Label, Safety and Feasibility Clinical Trial
Contact: Dr. Ivan da Silva (PI) – (352) 273-9000; Magali Jorand-Fletcher (CRC) – (352) 294-5391
Enrolling hours: 24/7
Diagnosis: Traumatic Brain Injury (TBI)
Objective: To evaluate safety and feasibility of controlled CSF external lumbar drainage in reducing ICP burden and improving outcomes of select severe TBI patients.
Inclusion Criteria:
- 18-65 years age
- Glasgow Coma Scale (GCS) 3-8
- Pupils symmetric and bilaterally reactive
- Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT
- Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT
- First randomization and intervention may be commenced within 24 hours of injury
- ELD safety score ≥5
Exclusion Criteria:
- GCS>8
- Cisterns on CT completely effaced
- Midline shift on CT >5mm
- GCS 3 with dilated and fixed pupils
- Uncal or tonsillar herniation on admission or post-operative brain CT
- Temporal lobe contusions
- Penetrating TBI
- Primary decompressive craniectomy (Craniotomy with bone flap replacement can be included)
- Pregnancy
- Prisoners
- Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care
- Pre-existing conditions affecting functional status or life expectancy to less than 1 year
- Contraindications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia <50,000, or severe spinal deformity, midline shift on CT >5mm