Research Traumatology, Surgical Critical Care and Emergency Surgery
Brain Oxygen Monitoring in TBI
Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen (pBrO2) Monitoring in the Management of Severe Traumatic Brain Injury
Key Inclusion Criteria
Male and female patients with severe TBI who require ICP monitoring
Non-penetrating traumatic brain injury
Requirement for intracranial pressure (ICP) monitoring will be based on the following criteria
GCS is 3-8 (measured off sedatives or paralytics) with abnormal CT scan. If patient is intubated, motor GCS < 4 required
If CT scan normal, motor GCS < 4 (measured off sedatives or paralytics).
Intoxication is not a reason for deferring ICP monitoring if above criteria are met.
If the patient has a witnessed seizure, wait 30 minutes to evaluate GCS.
Age 18-70 years
Randomization and placement of monitor within 12 hours of injury
Patients must speak English.
Key Exclusion Criteria
GCS motor score > 4 with normal CT scan
bilaterally absent pupillary responses
Coagulopathy that makes insertion of parenchymal monitors contraindicated (Platelets < 50,000/mL, INR > 1.4). (Enrollment allowed if coagulopathy can be corrected before 12 hour post-injury deadline).
Systemic sepsis at the time of screening
Refractory hypotension (SBP < 70 mm Hg for > 30 minutes)
Refractory systemic hypoxia (paO2 < 60 mm Hg on FiO2 < 0.5)
Evidence of premorbid disabling conditions that interfere with outcome assessment. These include diagnosis of Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, spinal cord injury with deficits, history of stroke, brain tumors, chronic use of medication for disabling neurologic or psychiatric disorder, or history of suicide attempt within the past year.
Imminent death or current life-threatening disease
Previous TBI hospitalization greater than 1 day.
Individuals who hold religious beliefs against blood transfusion.
Patients who are unlikely to be available for follow-up interview, even by telephone. For example, patients who are homeless, illegal aliens, or live in foreign countries and those with whom future personal (including family) or telephone contact is unlikely.