Status:
COMPLETED
Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
University of Washington
University of Miami
Conditions:
Severe Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a T...
Detailed Description
Design and Outcomes This study is a two-arm, single-blind, randomized, controlled, phase II, multi-center pilot trial of the efficacy of pBrO2 monitoring, and is designed to obtain data required for ...
Eligibility Criteria
Inclusion
- Non-penetrating traumatic brain injury
- Requirement for intracranial pressure monitoring according to Guidelines for the Management of Severe TBI, as operationalized below:
- GCS 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.
- Randomization and placement of monitors within 12 hours of injury.
- Males and females Age 18-70 years, English or Spanish speaking patients.
Exclusion
- Specific clinical contraindications:
- GCS motor score \> 4 with normal CT scan
- Bilaterally absent pupillary responses
- Laboratory contraindications per safety considerations:
- 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).
- Pregnant females will be excluded. Blood test for pregnancy is a routine part of care in ED's. However, if not done, a urine or blood test will be done as a safety precaution after consent but prior to study treatment.
- Monitoring with pBrO2 monitor prior to randomization.
- Clinical, demographic and other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
- 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
- Prisoner
- Individuals who hold religious beliefs against blood transfusion
- Previous TBI hospitalization greater than 1 day
- 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.
- Active drug or alcohol use or dependence that, in the opinion of the stie investigator, would interfere with follow-up.
- Imminent death or current life-threatening disease
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent
- Participation in other observational or interventional clinical trials is allowed as long as the PI of each study agree ahead of time to allow co-enrollment.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00974259
Start Date
October 1 2009
End Date
December 1 2014
Last Update
September 26 2019
Active Locations (10)
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1
University of Miami/Jackson Memorial Hospital
Miami, Florida, United States, 33136
2
Duke University
Durham, North Carolina, United States, 27710
3
University of Cincinnati
Cincinnati, Ohio, United States
4
Ohio State University
Columbus, Ohio, United States