Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Spinal Cord Injury, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02991690
• Other study ID #: 20160758
• Secondary ID: CDMRP-AR15018720
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: George Jimsheleishvili, MD
• Phone: 305-243-4781
• Email: gxj150[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Spinal Cord Injuries
• Spinal Cord Injury, Acute
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Prisma Health - University of South Carolina	Columbia	South Carolina
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Jackson Memorial Hospital	Miami	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	HonorHealth Research Institute with Barrow Brain and Spine	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological improvement on American Spinal Injury Association (ASIA)	Improvement in ASIA Impairment Scale (AIS) after modest hypothermia	Between baseline and 12 months
Primary	Neurological improvement on ASIA	Improvement in ASIA motor score after modest hypothermia	Between baseline and 12 months
Secondary	Functional improvement in Functional Independence Measure (FIM)	Functional improvement in FIM after modest hypothermia	12 months
Secondary	Functional improvement in Spinal Cord Independence Measure (SCIM)	Functional improvement in SCIM after modest hypothermia	12 months