Clinical trial NCT02991690: Systemic Hypothermia in Acute Cervical Spinal Cord Injury
Official title: Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury, Acute
Keywords: Hypothermia
Cervical Spinal Cord Injury
Trauma
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-12-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neurological improvement on American Spinal Injury Association (ASIA)
timeFrame: Between baseline and 12 months
measure: Neurological improvement on ASIA
timeFrame: Between baseline and 12 months
Secondary outcomes:
measure: Functional improvement in Functional Independence Measure (FIM)
timeFrame: 12 months
measure: Functional improvement in Spinal Cord Independence Measure (SCIM)
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth Research Institute with Barrow Brain and Spine
state: Arizona
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health - University of South Carolina
state: South Carolina
Study officials:
affiliation: University of Miami
name: Allan D Levi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.