RECRUITING

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

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Conditions

Spinal Cord Injury, AcuteHypothermiaCervical Spinal Cord InjuryTrauma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2017-08-04
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02991690

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 - 70 years of age
  2. * AIS Grade A - C
  3. * Glasgow Coma Scale ≥14
  4. * Able to start hypothermia treatment within 24 hours of injury
  5. * Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.
  1. * Age \> 70 years
  2. * AIS Grade D
  3. * Hyperthermia on admission (\>38.5ºC)
  4. * Severe systemic injury
  5. * Severe bleeding
  6. * Pregnancy
  7. * Coagulopathy
  8. * Thrombocytopenia
  9. * Known prior severe cardiac history
  10. * Blood dyscrasia
  11. * Pancreatitis
  12. * Reynaud's syndrome
  13. * Cord transection

Contacts and Locations

Study Contact

George Jimsheleishvili, MD
CONTACT
305-243-4781
gxj150@miami.edu

Principal Investigator

Allan D Levi, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

HonorHealth Research Institute with Barrow Brain and Spine
Phoenix, Arizona, 85027
United States
Jackson Memorial Hospital
Miami, Florida, 33136
United States
Emory University School of Medicine
Atlanta, Georgia, 30303-3049
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202-1000
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-5125
United States
Prisma Health - University of South Carolina
Columbia, South Carolina, 29203
United States

Collaborators and Investigators

Sponsor: University of Miami

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-04
Study Completion Date2025-09

Study Record Updates

Study Start Date2017-08-04
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Hypothermia
  • Cervical Spinal Cord Injury
  • Trauma

Additional Relevant MeSH Terms

  • Spinal Cord Injury, Acute