Systemic Hypothermia in Acute Cervical Spinal Cord Injury

NCT ID: NCT02991690

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-04
• Study Completion Date: 2026-09-30

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).

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.

Conditions

Spinal Cord Injury, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypothermia

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

Group Type: EXPERIMENTAL

Hypothermia

Intervention Type: 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.

Control

Standard of care medical treatment, specific to each individual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Allan D. Levi

Professor and Chairman of Neurological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allan D Levi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

HonorHealth Research Institute with Barrow Brain and Spine

Phoenix, Arizona, United States

Site Status: RECRUITING

Jackson Memorial Hospital

Miami, Florida, United States

Site Status: RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status: TERMINATED

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status: TERMINATED

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Prisma Health - University of South Carolina

Columbia, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

George Jimsheleishvili, MD

Role: CONTACT

gxj150@miami.edu

305-243-4781

Facility Contacts

Camille Fajardo, CCRC

Role: primary

cafajardo@honorhealth.com

623-879-1692

George Jimsheleishvili, MD

Role: primary

305-243-4781

Leslie Sult, BSN, RN

Role: primary

lsult@som.umaryland.edu

410-328-3657

James Harrop, MD

Role: primary

Paisley Myers, PhD

Role: primary

paisley.myers@prismahealth.org

803-296-9274

References

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.

Reference Type: BACKGROUND

PMID: 20190669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23247015 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19271964 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35013548 (View on PubMed)

Other Identifiers

CDMRP-SC150063

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20160365

Identifier Type: OTHER

Identifier Source: secondary_id

20160758

Identifier Type: -

Identifier Source: org_study_id