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Systemic Hypothermia in Acute Cervical Spinal Cord Injury
Recruiting
Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Who can join
Ages 18 to 70 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \> 70 years * AIS Grade D * Hyperthermia on admission (\>38.5ºC) * Severe systemic injury * Severe bleeding * Pregnancy * Coagulopathy * Thrombocytopenia * Known prior severe cardiac history * Blood dyscrasia * Pancreatitis * Reynaud's syndrome * Cord transection
About the study
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).
What is being tested
- Alsius Icy CoolGuard® Catheter (device)
Sponsor: University of Miami · Participants: 120 · Started: Aug 4, 2017
Contact the study team
- George Jimsheleishvili, MD · Phone: 305-243-4781
Official record on ClinicalTrials.gov — NCT02991690
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.