Phase II, randomized controlled trial of brain tissue oxygen monitoring

  • Bullock, Ross, (PI)
  • Diaz-Arrastia, Ramon (PI)
  • Temkin, Nancy (PI)
  • Le Roux, Peter (PI)
  • Chesnut, Randall (PI)
  • Madden, Christopher (PI)

Project: Research project

Description

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI) is a major cause of death and disability. In the United States alone approximately 1.4 million sustain a TBI each year, of which 50,000 people die, and over 200,000 are hospitalized. The acute management of TBI is aimed at preventing secondary neuronal injury, which results from a variety of mechanisms, prominently among them tissue ischemia. Recently, it has become 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 ICUs. The proposed study will be 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 to be monitored with 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. This study has one primary and several secondary hypotheses: (1) Treatment protocol based on pBrO2 monitoring results in reduction of tissue hypoxia. (2). Safety hypotheses: Adverse events associated with pBrO2 monitoring are rare (
StatusFinished
Effective start/end date9/30/098/31/14

Funding

  • National Institutes of Health: $749,198.00
  • National Institutes of Health: $777,874.00
  • National Institutes of Health: $834,154.00

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Randomized Controlled Trials
Oxygen
Brain
Partial Pressure
Wounds and Injuries
Clinical Protocols
Group Psychotherapy
Observational Studies
Intensive Care Units
Cause of Death
Ischemia
Traumatic Brain Injury
Technology
Safety
Control Groups
Therapeutics

ASJC

  • Medicine(all)
  • Neuroscience(all)