Spinal Cord Injury, Acute
Conditions
Keywords
Hypothermia, Cervical Spinal Cord Injury, Trauma
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.
Interventions
DEVICEAlsius 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.
Sponsors
University of Miami
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological improvement on American Spinal Injury Association (ASIA) | Between baseline and 12 months | Improvement in ASIA Impairment Scale (AIS) after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function |
| Neurological improvement on ASIA | Between baseline and 12 months | Improvement in ASIA motor score after modest hypothermia. ASIA Motor Score: 0-100, with higher scores indicating better motor function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement in Functional Independence Measure (FIM) | 12 months | Functional improvement in FIM after modest hypothermia. FIM score 18-126, with higher scores indicating greater functional independence |
| Functional improvement in Spinal Cord Independence Measure (SCIM) | 12 months | Functional improvement in SCIM after modest hypothermia. SCIM score 0-100, with higher scores indicating greater independence in activities of daily living |
Countries
United States
Contacts
CONTACTGeorge Jimsheleishvili, MD
PRINCIPAL_INVESTIGATORAllan D Levi, MD, PhD
University of Miami
Outcome results
None listed