Recruiting

Systemic Hypothermia

Sponsor:

University of Miami

Code:

NCT02991690

Conditions

Spinal Cord Injury, Acute

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Alsius Icy CoolGuard® Catheter

Study Details

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

Study ID

NCT02991690

Start date

Aug 4, 2017

Status verified date

Aug, 2026

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intravascular Hypothermia

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

no intervention: Control

Standard of care medical treatment, specific to each individual.

Interventions

Alsius Icy CoolGuard® Catheter

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.

Primary outcome measure

  • Neurological improvement on American Spinal Injury Association (ASIA) [ Time Frame: Between baseline and 12 months ]
  • Neurological improvement on ASIA [ Time Frame: Between baseline and 12 months ]

Central Contacts and Locations

Central contacts

George Jimsheleishvili, MD

305-243-4781gxj150@miami.edu

Locations

HonorHealth Research Institute with Barrow Brain and Spine

Recruiting

Phoenix, Arizona, United States, 85027

Contacts

Camille Fajardo, CCRC

623-879-1692cafajardo@honorhealth.com

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

George Jimsheleishvili, MD

305-243-4781

University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Leslie Sult, BSN, RN

410-328-3657lsult@som.umaryland.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107-5125

Prisma Health - University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Paisley Myers, PhD

803-296-9274paisley.myers@prismahealth.org

More Information

Sponsor

University of Miami

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Hypothermia
  • Cervical Spinal Cord Injury
  • Trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-26.