Using hypothermia to treat acute cervical spinal cord injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• HonorHealth Research Institute with Barrow Brain and Spine
  Phoenix, Arizona, United States Recruiting
• Jackson Memorial Hospital
  Miami, Florida, United States Recruiting
• 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
• Emory University School of Medicine
  Atlanta, Georgia, United States Terminated

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.