Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multi-center Case Controlled Study
University of Miami
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).
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 soc…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- 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
Interventions
- OtherHypothermia
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.
Locations (7)
- HonorHealth Research Institute with Barrow Brain and SpinePhoenix, Arizona
- Jackson Memorial HospitalMiami, Florida
- Emory University School of MedicineAtlanta, Georgia
- Indiana University School of MedicineIndianapolis, Indiana
- University of Maryland School of MedicineBaltimore, Maryland
- Thomas Jefferson UniversityPhiladelphia, Pennsylvania