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Spinal Cord Injury, AcuteNCT02991690

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

A study testing Alsius Icy CoolGuard® Catheter in people with Spinal Cord Injury, Acute, run by University of Miami at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injury, Acute
What is being tested?
Alsius Icy CoolGuard® Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
7 sitesUnited States
Study dates
4 Aug 2017to 29 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • Age > 70 years
  • AIS Grade D
  • Hyperthermia on admission (>38.5ºC)
  • Severe systemic injury
  • Severe bleeding
  • Pregnancy
Show all 13Show fewer
  • Coagulopathy
  • Thrombocytopenia
  • Known prior severe cardiac history
  • Blood dyscrasia
  • Pancreatitis
  • Reynaud's syndrome
  • Cord transection

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

George Jimsheleishvili, MD contact

305-243-4781

gxj150@miami.edu

7 sites in 1 country

United States7 sites, 5 recruiting

  • Emory University School of Medicine

    Atlanta, Georgia, 30303-3049

    Terminated

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

    Leslie Sult, BSN, RN, 410-328-3657, lsult@som.umaryland.edu

    Recruiting

  • Prisma Health - University of South Carolina

    Columbia, South Carolina, 29203

    Paisley Myers, PhD, 803-296-9274, paisley.myers@prismahealth.org

    Recruiting

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202-1000

    Terminated

  • Jackson Memorial Hospital

    Miami, Florida, 33136

    George Jimsheleishvili, MD, 305-243-4781

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107-5125

    James Harrop, MD

    Recruiting

  • HonorHealth Research Institute with Barrow Brain and Spine

    Phoenix, Arizona, 85027

    Camille Fajardo, CCRC, 623-879-1692, cafajardo@honorhealth.com

    Recruiting

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Alsius Icy CoolGuard® Catheter
Keywords
Hypothermia, Cervical Spinal Cord Injury, Trauma
Medical subject headings
Spinal Cord Injuries, Hypothermia, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alsius Icy CoolGuard® CatheterDevice

    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.

Study groups in NCT02991690
Study groupRoleWhat they receive
Intravascular HypothermiaExperimentalIntravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
Receives: Device: Alsius Icy CoolGuard® Catheter
ControlNo interventionStandard of care medical treatment, specific to each individual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurological improvement on American Spinal Injury Association (ASIA)

    Improvement in ASIA Impairment Scale (AIS) after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function

    Measured: Between baseline and 12 months

  2. Neurological improvement on ASIA

    Improvement in ASIA motor score after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function

    Measured: Between baseline and 12 months

Secondary outcomes (2)

  1. Functional improvement in Functional Independence Measure (FIM)

    Functional improvement in FIM after modest hypothermia. FIM score 18-126, with higher scores indicating greater functional independence

    Measured: 12 months

  2. Functional improvement in Spinal Cord Independence Measure (SCIM)

    Functional improvement in SCIM after modest hypothermia. SCIM score 0-100, with higher scores indicating greater independence in activities of daily living

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2016 (estimated)
  2. Study start4 Aug 2017
  3. Primary completion29 Sep 2027 (estimated)
  4. Study completion29 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991690
Sponsor's protocol ID
20160758
Other IDs
CDMRP-AR150187
Status last verified
Aug 2026
First submitted
7 Dec 2016
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 20190669

  • 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.

    PubMed 23247015

  • 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.

    PubMed 19271964

  • 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.

    PubMed 35013548

Questions about this trial

What is this clinical trial studying?

A study testing Alsius Icy CoolGuard® Catheter in people with Spinal Cord Injury, Acute, run by University of Miami at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact George Jimsheleishvili, MD (305-243-4781, gxj150@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological improvement on American Spinal Injury Association (ASIA) (time frame: Between baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02991690, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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