Systemic Hypothermia in Acute Cervical Spinal Cord Injury
- Conditions
- Spinal Cord Injury, Acute
- Interventions
- Other: Hypothermia
- Registration Number
- NCT02991690
- Lead Sponsor
- University of Miami
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypothermia Hypothermia Intravascular hypothermia will be initiated within 24 hours post-injury and 33 degrees Celsius will be maintained for 48 hours.
- Primary Outcome Measures
Name Time Method Neurological improvement on American Spinal Injury Association (ASIA) Between baseline and 12 months Improvement in ASIA Impairment Scale (AIS) after modest hypothermia
Neurological improvement on ASIA Between baseline and 12 months Improvement in ASIA motor score after modest hypothermia
- Secondary Outcome Measures
Name Time Method Functional improvement in Functional Independence Measure (FIM) 12 months Functional improvement in FIM after modest hypothermia
Functional improvement in Spinal Cord Independence Measure (SCIM) 12 months Functional improvement in SCIM after modest hypothermia
Trial Locations
- Locations (7)
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Prisma Health - University of South Carolina
🇺🇸Columbia, South Carolina, United States
HonorHealth Research Institute with Barrow Brain and Spine
🇺🇸Phoenix, Arizona, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States