Systemic Hypothermia in Acute Cervical Spinal Cord Injury

NCT02991690 | Recruiting DMC

• 3 other identifiers: 20160758CDMRP-SC15006320160365
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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).

Conditions

Spinal Cord Injury, Acute

Keywords

Hypothermia; Cervical Spinal Cord Injury; Trauma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional improvement in Functional Independence Measure (FIM)

  12 months

• Functional improvement in Spinal Cord Independence Measure (SCIM)

  12 months

Study Arms (2)

Hypothermia

EXPERIMENTAL

Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.

Other: Hypothermia

Control

NO INTERVENTION

Standard of care medical treatment, specific to each individual.

Interventions

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.

Hypothermia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• United States Department of Defense: collaborator

Study Sites (7)

HonorHealth Research Institute with Barrow Brain and Spine

Phoenix, Arizona, 85027, United States

RECRUITING

Jackson Memorial Hospital

Miami, Florida, 33136, United States

RECRUITING

Emory University School of Medicine

Atlanta, Georgia, 30303-3049, United States

TERMINATED

Indiana University School of Medicine

Indianapolis, Indiana, 46202-1000, United States

TERMINATED

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-5125, United States

RECRUITING

Prisma Health - University of South Carolina

Columbia, South Carolina, 29203, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 20190669 BACKGROUND

• 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.

  PMID: 23247015 BACKGROUND

• 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.

  PMID: 19271964 BACKGROUND

• 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.

  PMID: 35013548 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Hypothermia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allan D Levi, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Jimsheleishvili, MD

CONTACT

305-243-4781; gxj150@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Neurological Surgery

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 13, 2016
• Study Start: August 4, 2017
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)