Severe Traumatic Brain Injury Clinical Trial
— BOOST 2Official title:
Phase 2, Randomized Clinical Trial of the Safety and Efficacy of Brain Tissue Oxygen Monitoring in the Management of Severe Traumatic Brain Injury.
Verified date | September 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 TBI, of which 50,000 people die, and another 235,000 are hospitalized and
survive the injury. As a result, 80,000-90,000 people experience permanent disability
associated with TBI. This project is designed to determine whether a device designed to
measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially
treatable shows promise in reducing the duration of brain ischemia, and to obtain information
required to conduct a definitive clinical trial of efficacy.
A recently approved device makes it feasible to directly and continuously monitor the partial
pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that
episodes of low pBrO2 are common and are associated with a poor outcome, and that medical
interventions are effective in improving pBrO2 in clinical practice. However, as there have
been no randomized controlled trials carried out to determine whether pBrO2 monitoring
results in improved outcome after severe TBI, use of this technology has not so far been
widely adopted in neurosurgical intensive care units (ICUs). This study is the first
randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data
required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at
treating pBrO2, and feasibility of standardizing a complex intensive care unit management
protocol across multiple clinical sites.
Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and
pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or
therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be
enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Parkland
Memorial Hospital, the University of Washington/Harborview Medical Center, the University of
Miami/Jackson Memorial Hospital, and the University of Pennsylvania/Hospital of the
University of Pennsylvania. Functional outcome will be assessed at 6-months after injury.
Status | Completed |
Enrollment | 122 |
Est. completion date | December 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
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: - 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. 3. Randomization and placement of monitors within 12 hours of injury. 4. Males and females Age 18-70 years, English or Spanish speaking patients. Exclusion Criteria: 1. Specific clinical contraindications: - GCS motor score > 4 with normal CT scan - Bilaterally absent pupillary responses 2. 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). 3. 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. 4. Monitoring with pBrO2 monitor prior to randomization. 5. 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. 6. Active drug or alcohol use or dependence that, in the opinion of the stie investigator, would interfere with follow-up. 7. Imminent death or current life-threatening disease 8. Inability or unwillingness of subject or legal guardian/representative to give written informed consent 9. 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Duke University | Durham | North Carolina |
United States | University of Miami/Jackson Memorial Hospital | Miami | Florida |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of Washington/Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Duke University, National Institute of Neurological Disorders and Stroke (NINDS), Ohio State University, Temple University, Thomas Jefferson University, University of Cincinnati, University of Miami, University of Pittsburgh, University of Washington |
United States,
Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fraction of Time That Brain Oxygen Levels Are Below the Critical Threshold of 20 mm Hg . | Proportion of time PbtO2 below 20 mm Hg | 5 days | |
Secondary | Total Number Participants With Adverse Events Associated With PbtO2 Monitoring. | Total number participants with PbtO2 directed intervention-related Serious Adverse Events | 5 days | |
Secondary | Adherence to PbtO2 and ICP-directed Treatment Protocol | Number of protocol deviations and violations for ICP/PbtO2 group and ICP only group. The unit of measure for this outcome is number of events, where an event can be either a deviation or a violation. |
5 days | |
Secondary | Relative Risk of Good Outcome of ICP/PbtO2 Group Compared to ICP Only Group. | Dichotomized Glagow Outcome Score-Extended: GOSE 1-4 = Poor Outcome GOSE 5-8 = Good Outcome GOSE is a 8-point scale, with 1 = death, 8 = full recovery. |
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