Randomized Clinical Trial of the Safety and Efficacy of a Treatment Protocol, Based on Brain Tissue Oxygen (pBrO2) Monitoring in Patients with Severe Traumatic Brain Injury

Study ID
STU 112010-135

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact
Susie Madison
214-648-3948
susie.madison@utsouthwestern.edu

Principal Investigator
Christopher Madden

Summary

Legally authorized representatives of essentially comatose patients with severe brain injury admitted to Parkland Surgical intensive Care unit who require an intra-cranial pressure (iCP) monitor and a brain tissue oxygen (pBro2) monitor will be approached by research staff for consent and enrollment into this study within 12 hours from injury. after consent, the patient will be randomized into one of 2 arms of the study; iCP monitoring and treatment alone or both pBro2 and iCP monitoring and treatment.
Patients with this type of injury receive these 2 monitors as standard of care at Parkland. The monitors are not under review. They are FDa approved. The treatments are all standard of care. The order in which the treatments are done and whether or not it makes any difference in 6 month follow-up if the brain oxygen is monitored and treated are the things being studied.
The patients are monitored up to 5 days while in the hospital, or as long as the monitors are in. (5 days for primary outcome) 6 months after injury, patients (or caregivers) are interviewed by telephone using 3 interview instruments for about 20 min.

Participant Eligibility

Inclusion Criteria
(1). Non-penetrating traumatic brain injury
(2). Requirement for intracranial pressure monitoring according to Guidelines for the Management of Severe TBI, as operationalized below:
(3). GCS 3-8 (measured off sedatives or paralytics) with abnormal CT scan. If patient is intubated, motor GCS = or< 5 required.
(4). If CT scan normal, motor GCS =or< 5 (measured off sedatives or paralytics)
Note: Intoxication is not a reason for deferring ICP monitoring if above criteria are met.
(5). ICP and Licox monitor are in place or imminently about to be placed. Randomization and placement of Licox monitor are fesible within 12 hours of injury. Exception for enrolling a patient past the 12 hour window: A patient who is admitted to the hospital and later experiences neuroworsening that is not due to a systemic insult, (e.g. MI, arrhythmia, PE, systemic hemorrhage) but due to a presumptive intracranial cause, and subsequently requires a pBtO2 monitor, may be screened for enrollment. Consent, randomization, and monitor placement most be done within 48 hours from injury in order for the patient to qualify.
(6). Males and females Age 14 years and older, accepting any language in which the patient can be consented and interviewed at follow-up in 6 months.



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