Systemic Hypothermia in Acute Cervical Spinal Cord Injury
ConditionSpinal Cord Injury, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Miami
About this trial
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 criteria
Qualifiers
18 - 70 years of age
AIS Grade A - C
Glasgow Coma Scale ≥14
Able to start hypothermia treatment within 24 hours of injury
Disqualifiers
Age > 70 years
AIS Grade D
Hyperthermia on admission (>38.5ºC)
Severe systemic injury
Trial design
Treatments tested in this trial
- Hypothermia
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Miami
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov