120
Participants
Start Date
August 4, 2017
Primary Completion Date
August 31, 2026
Study Completion Date
September 30, 2026
Hypothermia
To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification \[510(k), K030421\]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.
RECRUITING
University of Maryland School of Medicine, Baltimore
RECRUITING
Prisma Health - University of South Carolina, Columbia
RECRUITING
Jackson Memorial Hospital, Miami
RECRUITING
HonorHealth Research Institute with Barrow Brain and Spine, Phoenix
TERMINATED
Emory University School of Medicine, Atlanta
TERMINATED
Indiana University School of Medicine, Indianapolis
RECRUITING
Thomas Jefferson University, Philadelphia
United States Department of Defense
FED
University of Miami
OTHER