Intravascular Hypothermia for Spinal Cord Injury

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Recruiting N/A Interventional Study
Spinal Cord Injury, Acute
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of Miami · Other
Who this trial is looking for

This trial is looking for adults with a recent cervical spinal cord injury. Participants will receive a treatment that lowers body temperature to see if it helps with recovery.

Are You a Good Fit for This Trial?
Rules you out Severe systemic injuryCoagulopathyThrombocytopeniaBlood dyscrasiaPancreatitisReynaud's syndrome

You may be able to join if

  • I am between 18 and 70 years old.
  • I have a spinal cord injury classified as AIS Grade A, B, or C.
  • I have a Glasgow Coma Scale score of 14 or higher.
  • I can start treatment within 24 hours of my injury.
  • I have a non-penetrating injury.

You may not be able to join if

  • I am older than 70 years old.
  • I have a spinal cord injury classified as AIS Grade D.
  • I have a fever over 38.5ºC when I arrive at the hospital.
  • I have severe bleeding.
  • I am pregnant.
  • I have a known bleeding disorder.
  • I have a severe heart condition.
  • I have had a spinal cord transection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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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).

Trial Locations
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Eligibility 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 \> 7…
Contacts

George Jimsheleishvili, MD

305-243-4781

gxj150@miami.edu

CONTACT