Brain Oxygen Optimization in Severe TBI, Phase 3

Launched by UNIVERSITY OF MICHIGAN · Nov 22, 2018

Keywords

ClinConnect Summary

The BOOST3 trial is a research study designed to compare two different ways of monitoring and treating patients with severe traumatic brain injuries (TBI) in the intensive care unit (ICU). The goal is to see whether a method that looks at both brain pressure and brain oxygen levels is more effective than a method that only focuses on brain pressure. Doctors use these monitoring strategies to adjust treatments, such as medications and fluids, to help patients recover. By finding out which method works better, the study aims to improve the care of patients with serious brain injuries.

To participate in this trial, patients must be at least 14 years old and have a specific type of brain injury that does not involve a break in the skull. They should have a certain level of consciousness, as measured by a scale called the Glasgow Coma Scale (GCS). Participants will have special probes placed in their brains to help monitor their condition. While in the study, patients will receive care based on the assigned monitoring strategy, and the research team will closely track their health and recovery. It’s important to know that not everyone with a brain injury will qualify for this trial, as certain medical conditions or situations may exclude them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Non-penetrating traumatic brain injury
• • Glasgow Coma Scale (GCS) 3-8 measured off paralytics
• • Glasgow Coma Scale motor score \< 6 if endotracheally intubated
• • Evidence of intracranial trauma on CT scan
• • Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
• • Able to place intracranial probes and randomize within 12 hours from injury
• • Age greater than or equal to 14 years
• Exclusion Criteria:
• • Non-survivable injury
• • Bilaterally absent pupillary response in the absence of paralytic medication
• • Contraindication to the placement of intracranial probes
• • Treatment of brain tissue oxygen values prior to randomization
• • Planned use of devices which may unblind treating physicians to brain tissue hypoxia
• • Systemic sepsis at screening
• • Refractory hypotension
• • Refractory systemic hypoxia
• • PaO2/FiO2 ratio \< 150
• • Known pre-existing neurologic disease with confounding residual neurological deficits
• • Known inability to perform activities of daily living (ADL) without assistance prior to injury
• • Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
• • Pregnancy
• • Prisoner
• • On EFIC Opt-Out list as indicated by a bracelet or medical alert