An interventional study of Alsius Icy CoolGuard® Catheter in Spinal Cord Injury, Acute, sponsored by University of Miami. Recruiting at 7 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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 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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 120 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
Device: Alsius Icy CoolGuard® Catheter
Standard of care medical treatment, specific to each individual.
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.
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
Time frame: Between baseline and 12 months
Neurological improvement on ASIA
Improvement in ASIA motor score after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function
Time frame: Between baseline and 12 months
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
Time frame: 12 months
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
Time frame: 12 months
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
Started Aug 2017 (actual). Primary completion is estimated for Sep 2027, 121 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 121 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
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