122
Participants
Start Date
October 31, 2009
Primary Completion Date
March 31, 2014
Study Completion Date
December 31, 2014
Management protocol based on pBrO2 and ICP values.
For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (\> 20 mm Hg) or pBrO2 (\< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time.
Management protocol based on ICP values only.
For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant.
University of Pennsylvania, Philadelphia
Duke University, Durham
University of Miami/Jackson Memorial Hospital, Miami
University of Texas Southwestern Medical Center, Dallas
University of Washington/Harborview Medical Center, Seattle
University of Cincinnati, Cincinnati
Ohio State University, Columbus
Temple University, Philadelphia
Thomas Jefferson University, Philadelphia
University of Pittsburgh, Pittsburgh
Collaborators (1)
University of Washington
OTHER
University of Miami
OTHER
University of Pittsburgh
OTHER
Duke University
OTHER
Ohio State University
OTHER
Temple University
OTHER
Thomas Jefferson University
OTHER
University of Cincinnati
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Pennsylvania
OTHER