Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT02991690

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Led by University of Miami · Updated on 2025-11-21

120

Participants Needed

7

Research Sites

473 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years
  • American Spinal Injury Association (AIS) grade A, B, or C
  • Glasgow Coma Scale score of 14 or higher
  • Able to start hypothermia treatment within 24 hours of injury
  • Non-penetrating spinal cord injury or urgent surgical reduction cases
Not Eligible

You will not qualify if you...

  • Age over 70 years
  • AIS grade D
  • Hyperthermia on admission (temperature over 38.56C)
  • Severe systemic injury
  • Severe bleeding
  • Pregnancy
  • Coagulopathy
  • Thrombocytopenia
  • Known prior severe cardiac history
  • Blood dyscrasia
  • Pancreatitis
  • Reynaud's syndrome
  • Spinal cord transection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

HonorHealth Research Institute with Barrow Brain and Spine

Phoenix, Arizona, United States, 85027

Actively Recruiting

2

Jackson Memorial Hospital

Miami, Florida, United States, 33136

Actively Recruiting

3

Emory University School of Medicine

Atlanta, Georgia, United States, 30303-3049

Terminated

4

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202-1000

Terminated

5

University of Maryland School of Medicine

Baltimore, Maryland, United States, 21201

Actively Recruiting

6

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107-5125

Actively Recruiting

7

Prisma Health - University of South Carolina

Columbia, South Carolina, United States, 29203

Actively Recruiting

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Research Team

G

George Jimsheleishvili, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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