Systemic Hypothermia in Acute Cervical Spinal Cord Injury
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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 : October 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injury, Acute | Other: Hypothermia | Not Applicable |
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 2023 |
Estimated Study Completion Date : | August 2024 |

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.
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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.
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- Neurological improvement on American Spinal Injury Association (ASIA) [ Time Frame: Between baseline and 12 months ]Improvement in ASIA Impairment Scale (AIS) after modest hypothermia
- Neurological improvement on ASIA [ Time Frame: Between baseline and 12 months ]Improvement in ASIA motor score after modest hypothermia
- Functional improvement in Functional Independence Measure (FIM) [ Time Frame: 12 months ]Functional improvement in FIM after modest hypothermia
- Functional improvement in Spinal Cord Independence Measure (SCIM) [ Time Frame: 12 months ]Functional improvement in SCIM after modest hypothermia

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: George Jimsheleishvili, MD | 305-243-4781 | gxj150@miami.edu |
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 |
Principal Investigator: | Allan D Levi, MD, PhD | University of Miami |
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: | October 12, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypothermia Cervical Spinal Cord Injury Trauma |
Spinal Cord Injuries Hypothermia Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Body Temperature Changes |