A Randomized, Open Label Clinical Trial of Sustained Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury
Inclusion Criteria:
- Adults (18 - 60 years old)
- Severe traumatic brain injury with intracranial pressure monitoring
- Initial GCS 5-8 (obtained free of the effects of neuromuscular blockade or sedatives)
- Clearly defined time of injury no more than 8 hours before administration of study
drug
- Written consent obtained from legally authorized representative (LAR)
- Severe swelling prone injury patterns:
1. Contusion - frontal or temporal (> 20 cc)
2. Acute convexity subdural hematoma with any evidence of midline shift
Exclusion Criteria:
- Patients undergoing emergent (within 15 minutes) or urgent neurosurgery (within 4
hours) following emergency department arrival (bedside procedures, such as
intracranial pressure monitor placement are excluded)
- Posterior fossa lesions
- Penetrating brain injury
- Spinal column instability and/or spinal cord injury with neurological deficit
- Pregnant
- Concomitant severe nonsurvivable injury
- Acute renal failure ; Chronic renal failure (serum creatinine of > 2.5 mg/dL, history
of ongoing dialysis, glomerular filtration rate <30mL/min/1.73 m2); Severe pulmonary
edema; Severe heart failure; Severe liver failure (AST, ALT, or bilirubin > 2 times
normal)
- Known use of warfarin, clopidogrel, prasugrel, cilostazol, heparin, low molecular
weight heparin, heparinoids, abciximab or similar antiplatelet agents
- Treatment with another investigational drug within the prior 30 days
- Systolic blood pressure < 90 mm HG not responsive to fluid resuscitation
- INR > 1.4
- Hospitalization for brain injury or neurological disease within previous 3 years
- Admission serum sodium < 135 mmol/L
- > 8 hours from the time of injury to admission
- Fix/dilated pupil suspected to be secondary to brainstem compression
- Duret (brainstem) hemorrhage indicating brainstem herniation
- PaO2 < 60 mmHg on admission (when blood gases are drawn as standard of care)
- Prisoner or other persons unable to make a true, voluntary and uncoerced decision
whether or not to participate in the study