Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 18 - 70 years of age
• AIS Grade A - C
• Glasgow Coma Scale ≥14
• Able to start hypothermia treatment within 24 hours of injury
• Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.
Locations
United States
Arizona
HonorHealth Research Institute with Barrow Brain and Spine
RECRUITING
Phoenix
Florida
Jackson Memorial Hospital
RECRUITING
Miami
Georgia
Emory University School of Medicine
TERMINATED
Atlanta
Indiana
Indiana University School of Medicine
TERMINATED
Indianapolis
Maryland
University of Maryland School of Medicine
RECRUITING
Baltimore
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
South Carolina
Prisma Health - University of South Carolina
RECRUITING
Columbia
Contact Information
Primary
George Jimsheleishvili, MD
gxj150@miami.edu
305-243-4781
Time Frame
Start Date: 2017-08-04
Estimated Completion Date: 2026-09
Participants
Target number of participants: 120
Treatments
Experimental: Hypothermia
Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
No_intervention: Control
Standard of care medical treatment, specific to each individual.
Authors
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Miami