Systemic Hypothermia in Acute Cervical Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Cord Injury, Acute

Intervention / Treatment
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* Other: Hypothermia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypothermia<br>Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours. | Other: Hypothermia<br>* 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.<br>|
| No Intervention: Control<br>Standard of care medical treatment, specific to each individual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological improvement on American Spinal Injury Association (ASIA) | Improvement in ASIA Impairment Scale (AIS) after modest hypothermia | Between baseline and 12 months | 
| Neurological improvement on ASIA | Improvement in ASIA motor score after modest hypothermia | Between baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional improvement in Functional Independence Measure (FIM) | Functional improvement in FIM after modest hypothermia | 12 months | 
| Functional improvement in Spinal Cord Independence Measure (SCIM) | Functional improvement in SCIM after modest hypothermia | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Cervical Spinal Cord Injury, Trauma