Systemic Hypothermia in Acute Cervical Spinal Cord Injury

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

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury, Acute
• Intervention / Treatment: Other: Hypothermia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: George Jimsheleishvili, MD; Phone Number: 305-243-4781; Email: gxj150@miami.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Recruiting
      • HonorHealth Research Institute with Barrow Brain and Spine
      • Contact: Camille Fajardo, CCRC; Phone Number: 623-879-1692; Email: cafajardo@honorhealth.com
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital
      • Contact: George Jimsheleishvili, MD; Phone Number: 305-243-4781
  • Georgia
    • Atlanta, Georgia, United States, 30303-3049
      • Terminated
      • Emory University School Of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46202-1000
      • Terminated
      • Indiana University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland School of Medicine
      • Contact: Leslie Sult, BSN, RN; Phone Number: 410-328-3657; Email: lsult@som.umaryland.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107-5125
      • Recruiting
      • Thomas Jefferson University
      • Contact: James Harrop, MD
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Prisma Health - University of South Carolina
      • Contact: Paisley Myers, PhD; Phone Number: 803-296-9274; Email: paisley.myers@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypothermia; Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.	Other: Hypothermia; 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.
No Intervention: Control; Standard of care medical treatment, specific to each individual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological improvement on American Spinal Injury Association (ASIA)	Improvement in ASIA Impairment Scale (AIS) after modest hypothermia	Between baseline and 12 months
Neurological improvement on ASIA	Improvement in ASIA motor score after modest hypothermia	Between baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional improvement in Functional Independence Measure (FIM)	Functional improvement in FIM after modest hypothermia	12 months
Functional improvement in Spinal Cord Independence Measure (SCIM)	Functional improvement in SCIM after modest hypothermia	12 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Allan D Levi, MD, PhD, University of Miami

Publications and helpful links

General Publications

• Levi AD, Casella G, Green BA, Dietrich WD, Vanni S, Jagid J, Wang MY. Clinical outcomes using modest intravascular hypothermia after acute cervical spinal cord injury. Neurosurgery. 2010 Apr;66(4):670-7. doi: 10.1227/01.NEU.0000367557.77973.5F.
• Dididze M, Green BA, Dietrich WD, Vanni S, Wang MY, Levi AD. Systemic hypothermia in acute cervical spinal cord injury: a case-controlled study. Spinal Cord. 2013 May;51(5):395-400. doi: 10.1038/sc.2012.161. Epub 2012 Dec 18.
• Levi AD, Green BA, Wang MY, Dietrich WD, Brindle T, Vanni S, Casella G, Elhammady G, Jagid J. Clinical application of modest hypothermia after spinal cord injury. J Neurotrauma. 2009 Mar;26(3):407-15. doi: 10.1089/neu.2008.0745.
• Vedantam A, Jimsheleishvili G, Harrop JS, Alberga LR, Ahmad FU, Murphy RK, Jackson JB 3rd, Rodgers RB, Levi AD. A prospective multi-center study comparing the complication profile of modest systemic hypothermia versus normothermia for acute cervical spinal cord injury. Spinal Cord. 2022 Jun;60(6):510-515. doi: 10.1038/s41393-021-00747-w. Epub 2022 Jan 10.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2017
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hypothermia; Cervical Spinal Cord Injury; Trauma
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Spinal Cord Injuries; Hypothermia
• Other Study ID Numbers: 20160758; 20160365 (Other Identifier: University of Miami IRB); CDMRP-SC150063 (Other Grant/Funding Number: United States Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No