Using hypothermia to treat acute cervical spinal cord injuries
Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
This study is testing if cooling the body to a specific temperature can help people with recent neck injuries recover better and improve their chances of regaining movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT02991690 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of intravascular hypothermia at a temperature of 33ºC for patients with acute cervical spinal cord injuries. It is a prospective multi-center trial involving several prominent medical institutions. The study seeks to initiate hypothermia treatment within 24 hours of injury to potentially improve neurological outcomes for patients suffering from spinal cord injuries. By demonstrating the benefits of this approach, the trial hopes to enhance patient recovery and reduce long-term dependency on caregivers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with acute cervical spinal cord injuries classified as AIS Grade A to C.
Not a fit: Patients over 70 years old or those with AIS Grade D injuries are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients with acute cervical spinal cord injuries.
How similar studies have performed: Previous studies have shown promise in using hypothermia for neurological injuries, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Phoenix, Arizona and 6 other locations
- HonorHealth Research Institute with Barrow Brain and Spine — Phoenix, Arizona, United States (Recruiting)
- Jackson Memorial Hospital — Miami, Florida, United States (Recruiting)
- Emory University School of Medicine — Atlanta, Georgia, United States (Terminated)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Terminated)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
- Prisma Health - University of South Carolina — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Allan D Levi, MD, PhD — University of Miami
- Study coordinator: George Jimsheleishvili, MD
- Email: gxj150@miami.edu
- Phone: 305-243-4781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.