Systemic Hypothermia for Acute Cervical Spinal Cord Injury
This study is looking at whether cooling the body (intravascular hypothermia) can help people who have recently experienced a cervical (neck) spinal cord injury. Researchers will use a special catheter, the Alsius Icy CoolGuard® catheter, inserted into a vein to cool the body to 33 degrees Celsius (modest hypothermia). The goal is to see if this treatment is safe and if it can improve how well people recover from their injury. You might be able to join if you are between 18 and 70 years old, have a certain type of spinal cord injury (AIS Grade A-C), and can start the cooling treatment within 24 hours of your injury. Success in this study would mean that participants show improvement in their neurological function, as measured by the American Spinal Injury Association (ASIA) scale, between the start of the study and 12 months later. The current status of this study is unclear.
- Study design
- This is a prospective multi-center study aiming to enroll 120 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for neurological improvement between baseline and 12 months after the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Systemic Hypothermia in Acute Cervical Spinal Cord Injury
At a glance
Conditions
NCT02991690
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
HonorHealth Research Institute with Barrow Brain and Spine
Phoenix, Arizonastudy coordinator listed
Recruiting
Jackson Memorial Hospital
Miami, Floridastudy coordinator listed
Recruiting
Prisma Health - University of South Carolina
Columbia, South Carolinastudy coordinator listed
Recruiting
University of Maryland School of Medicine
Baltimore, Marylandstudy coordinator listed
Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvaniano site contact published
Recruiting
Emory University School of Medicine
Atlanta, Georgiano site contact published
Terminated
Indiana University School of Medicine
Indianapolis, Indianano site contact published
Terminated
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Allan D Levi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Inclusion
Exclusion
What this trial measures
- Neurological improvement on American Spinal Injury Association (ASIA)Between baseline and 12 months
Improvement in ASIA Impairment Scale (AIS) after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function
- Neurological improvement on ASIABetween baseline and 12 months
Improvement in ASIA motor score after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function