Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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).
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Spine
Enrollment Eligibility
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