Cooling the body after a sudden neck spinal cord injury
Tests body cooling in adults with acute neck spinal cord injury.
Key facts
- Who runs it
- University of Miami
- Where
- Atlanta, Baltimore, Columbia, Indianapolis, Miami, Philadelphia, and Phoenix, United StatesSee the 7 sites
- Trial code
- Registry title
- Systemic Hypothermia in Acute Cervical Spinal Cord Injury
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 4 Aug 2017
- Expected to end
- 29 Sept 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Alsius Icy CoolGuard® Catheter
- Record updated
- 26 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent injury to the spinal cord in the neck (C1 to C8). It tests cooling the body to 33ºC with a catheter placed in a blood vessel.
- Age
- 18 to 70 years
- Sex
- All sexes
- Disease stage
- Acute neck spinal cord injury, AIS Grade A - C. The injury must not be penetrating. Glasgow Coma Scale ≥14 (awake and alert). Cooling must be able to start within 24 hours of the injury.
- Earlier treatment
- People rushed to the operating room for surgery to realign the spine can also join.
Main reasons for not taking part
- AIS Grade D injury, or the spinal cord is fully cut through
- Fever on admission (>38.5ºC)
- Severe injury elsewhere in the body or severe bleeding
- Pregnancy
- Blood clotting problems, low platelets, blood disorders, known severe heart history, pancreatitis or Reynaud's syndrome
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- Known prior severe cardiac history
- Severe bleeding
- Reynaud's syndrome
- Age > 70 years
- AIS Grade D
- Hyperthermia on admission (>38.5ºC)
- Severe systemic injury
- Pregnancy
- Coagulopathy
- Thrombocytopenia
- Blood dyscrasia
- Pancreatitis
- Cord transection
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Emory University School of MedicineAtlanta, United StatesContact: George Jimsheleishvili, MDNo longer taking part
- University of Maryland School of MedicineBaltimore, United StatesContact: Leslie Sult, BSN, RNTaking people
- Prisma Health - University of South CarolinaColumbia, United StatesContact: Paisley Myers, PhDTaking people
- Indiana University School of MedicineIndianapolis, United StatesContact: George Jimsheleishvili, MDNo longer taking part
- Jackson Memorial HospitalMiami, United StatesContact: George Jimsheleishvili, MDTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesContact: James Harrop, MDTaking people
- HonorHealth Research Institute with Barrow Brain and SpinePhoenix, United StatesContact: Camille Fajardo, CCRCTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Intravascular HypothermiaTreatment being tested
Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
Treatment: Alsius Icy CoolGuard® Catheter
- ControlNo study treatment, for comparison
Standard of care medical treatment, specific to each individual.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
- Plain-language title
- Cooling the body after a sudden neck spinal cord injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT02991690, who can take part
- Record updated
- 26 August 2026