Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Description

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

Spinal Cord Injury, Acute

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Study Overview

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Study Details

Study overview

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).

Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Condition
Spinal Cord Injury, Acute
Intervention / Treatment

-

Contacts and Locations

Phoenix

HonorHealth Research Institute with Barrow Brain and Spine, Phoenix, Arizona, United States, 85027

Miami

Jackson Memorial Hospital, Miami, Florida, United States, 33136

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30303-3049

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202-1000

Baltimore

University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107-5125

Columbia

Prisma Health - University of South Carolina, Columbia, South Carolina, United States, 29203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Allan D Levi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2025-09