Systemic Hypothermia in Acute Cervical Spinal Cord Injury
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injury, Acute
In brief
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).
Key facts
- Study ID
- NCT02991690
- Run by
- University of Miami
- People needed
- 120
- Starts
- 2017-08-04
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-11-21
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
- Prisma Health - University of South Carolina — Columbia, South Carolina, United States (enrolling)
- Jackson Memorial Hospital — Miami, Florida, United States (enrolling)
- HonorHealth Research Institute with Barrow Brain and Spine — Phoenix, Arizona, United States (enrolling)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (enrolling)
- Indiana University School of Medicine — Indianapolis, Indiana, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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