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Systemic Hypothermia in Acute Cervical Spinal Cord Injury

RecruitingNAAges 18 Years - 70 YearsAllUniversity of Miami
NCT02991690 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Alsius Icy CoolGuard® Catheter
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Where

7 sites
HonorHealth Research Institute with Barrow Brain and Spine
Phoenix, United States
Jackson Memorial Hospital
Miami, United States
Emory University School of Medicine
Atlanta, United States
Indiana University School of Medicine
Indianapolis, United States
University of Maryland School of Medicine
Baltimore, United States
Thomas Jefferson University
Philadelphia, United States
Prisma Health - University of South Carolina
Columbia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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