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Systemic Hypothermia in Acute Cervical Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991690
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Allan D. Levi, University of Miami

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury, Acute Other: Hypothermia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991690


Contacts
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Contact: George Jimsheleishvili, MD 305-243-4781 gxj150@miami.edu

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allan D. Levi, Professor and Chairman of Neurological Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT02991690    
Other Study ID Numbers: 20160758
CDMRP-AR150187 ( Other Grant/Funding Number: United States Department of Defense )
20160365 ( Other Identifier: University of Miami IRB )
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allan D. Levi, University of Miami:
Hypothermia
Cervical Spinal Cord Injury
Trauma
Additional relevant MeSH terms:
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Spinal Cord Injuries
Hypothermia
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Body Temperature Changes