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Systemic Hypothermia in Acute Cervical Spinal Cord Injury
Sponsor: University of Miami
Summary
This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).
Official title: Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2017-08-04
Completion Date
2026-09
Last Updated
2025-11-21
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (7)
HonorHealth Research Institute with Barrow Brain and Spine
Phoenix, Arizona, United States
Jackson Memorial Hospital
Miami, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Prisma Health - University of South Carolina
Columbia, South Carolina, United States