Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02991690

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the potential for clinical hypothermia following SCI to improve neurological outcome has significant value. Many patients suffering SCI become permanently dependent on caretakers and become a financial liability to both the family and society. Hypothermia has the potential to improve outcome so that more patients suffering SCI can regain independent motor and sensory function and remain economically productive members of society. The use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute SCI and may also have more widespread uses in patients presenting with stroke or cardiac arrest. In the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermia

Other

To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [510(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.

Primary outcomes

  1. Neurological improvement on American Spinal Injury Association (ASIA)

    Time frame: Between baseline and 12 months

    Improvement in ASIA Impairment Scale (AIS) after modest hypothermia

  2. Neurological improvement on ASIA

    Time frame: Between baseline and 12 months

    Improvement in ASIA motor score after modest hypothermia

Secondary outcomes

  1. Functional improvement in Functional Independence Measure (FIM)

    Time frame: 12 months

    Functional improvement in FIM after modest hypothermia

  2. Functional improvement in Spinal Cord Independence Measure (SCIM)

    Time frame: 12 months

    Functional improvement in SCIM after modest hypothermia

Study contacts

Contact information is provided by the study sponsor or research team.

George Jimsheleishvili, MD

CONTACT

[email protected]

305-243-4781

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2016
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.