1,094
Participants
Start Date
August 28, 2019
Primary Completion Date
November 1, 2027
Study Completion Date
November 1, 2027
ICP + PbtO2 guided management strategy
In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg and to avoid PbtO2 dropping below 20 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada for patients with severe TBI. The devices are used in standard care at hospitals participating in this research study. Doctors adjust their treatment choices to try to achieve these ICP and PbtO2 goals. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.
ICP guided management strategy
In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull, but PbtO2 is not used to guide care. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada, and are routinely used in patients with severe TBI. Doctors adjust their treatment choices to try to achieve this ICP goal. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.
RECRUITING
NYP Columbia University Medical Center, New York
RECRUITING
North Shore University Hospital, Manhasset
WITHDRAWN
Kings County Hospital Center, Brooklyn
RECRUITING
SUNY Upstate Medical University, Syracuse
RECRUITING
Strong Memorial Hospital, Rochester
RECRUITING
UPMC Presbyterian Hospital, Pittsburgh
RECRUITING
Penn Presbyterian Medical Center, Philadelphia
RECRUITING
Thomas Jefferson University Hospital, Philadelphia
WITHDRAWN
MedStar Washington Hospital Center, Washington D.C.
RECRUITING
University of Maryland Medical Center, Baltimore
RECRUITING
Johns Hopkins Hospital, Baltimore
RECRUITING
VCU Medical Center, Richmond
ACTIVE_NOT_RECRUITING
WVU Healthcare Ruby Memorial Hospital, Morgantown
RECRUITING
University of North Carolina Medical Center, Chapel Hill
RECRUITING
Duke University Hospital, Durham
RECRUITING
UF Health Shands Hospital, Gainesville
RECRUITING
OSU Wexner Medical Center, Columbus
ACTIVE_NOT_RECRUITING
Riverside Methodist Hospital, Columbus
RECRUITING
University of Cincinnati Medical Center, Cincinnati
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Detroit Receiving Hospital, Detroit
RECRUITING
Henry Ford Hospital, Detroit
RECRUITING
Froedtert Hospital, Milwaukee
RECRUITING
Regions Hospital, Saint Paul
RECRUITING
University of Chicago Medical Center, Chicago
RECRUITING
Parkland Hospital, Dallas
WITHDRAWN
Memorial Hermann Hospital, Houston
RECRUITING
Ben Taub General Hospital, Houston
RECRUITING
University of Texas Health Science Center San Antonio, San Antonio
ACTIVE_NOT_RECRUITING
University of Colorado Hospital, Aurora
RECRUITING
University of Utah Healthcare, Salt Lake City
RECRUITING
University of New Mexico Hospital, Albuquerque
RECRUITING
Cedars-Sinai Medical Center, Los Angeles
ACTIVE_NOT_RECRUITING
San Francisco General Hospital, San Francisco
RECRUITING
Stanford University Medical Center, Palo Alto
RECRUITING
UC Davis Medical Center, Sacramento
RECRUITING
Oregon Health & Science University Hospital, Portland
RECRUITING
Harborview Medical Center, Seattle
ACTIVE_NOT_RECRUITING
Ronald Reagan UCLA Medical Center, Los Angeles
RECRUITING
Yale New Haven Hospital, New Haven
RECRUITING
Maine Medical Center, Portland
RECRUITING
Massachusetts General Hospital, Boston
ACTIVE_NOT_RECRUITING
Beth Israel Deaconess Medical Center, Boston
RECRUITING
UMASS Memorial Medical Center, Worcester
RECRUITING
Cooper University Hospital, Camden
RECRUITING
University of Calgary - Foothills Medical Centre, Calgary
RECRUITING
St. Michaels Hospital, Toronto
RECRUITING
CIUSSS-NIM Hopital du Sacre - Coeur de Montreal, Montreal
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Washington
OTHER
University of Pennsylvania
OTHER
University of Pittsburgh
OTHER
Medical University of South Carolina
OTHER
University of Michigan
OTHER