Systemic Hypothermia in Acute Cervical Spinal Cord Injury - A Prospective, Multicenter Case-Controlled Study
Abstract
Spinal cord injury (SCI) is a devastating condition that exerts a disproportionate medical, social, and economic toll on society. However, to date, no therapeutic intervention has been demonstrated to definitively improve neurological outcomes or mitigate the effects of secondary neural injury. Modest hypothermia (cooling the body down to 33ºC) has been shown to improve neurological function and mitigate neuronal loss in numerous animal models. Our institution has an extended single center experience of using intravascular hypothermia for the treatment of cervical SCI patients for over 8 years. Our pilot clinical study has shown moderate hypothermia to be a safe and potentially efficacious intervention for SCI patients. Based upon this promising evidence, we propose to conduct a prospective multi-center trial (University of Miami/Jackson Memorial Hospital [UM/JMH], Emory University School of Medicine/Grady Memorial Hospital [EUSM/GMH], Thomas Jefferson University [TJU], and Indiana University School of Medicine [IU]) to recruit a total of 120 patients within a 4-year time period. Each site will randomize patients to both control and treatment groups (hypothermia). Center randomization will occur over sequential epochs -- with UM/JMH and EUSM/GMH to recruit 15 hypothermia patients each (over 2 years) -- and will switch to control recruitment over the next 2 years. IU and TJU will recruit 15 control patients and then switch to treatment -- again with 15 patients in each arm. This will insure equal numbers in both the control and treatment groups in each center. To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [501(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein. We will determine the safety profile and efficacy of modest intravascular hypothermia following acute cervical (C1 to C8) SCI. A prospective study enrollment using the combined experience of four centers with the largest number of acute SCI admissions per year in the country would go a long way in better understanding the potential benefits of hypothermia for SCI including its generalizability. Patients will be cooled at a maximum rate (2ºC-2.5ºC/hour) until they reach target temperature (33ºC), which will be maintained for 48 hours, and then re-warmed at 0.1ºC/hour until normothermia (37ºC) is achieved. Follow-up evaluations will be performed at 6 weeks, 6 months, and 1 year using AIS assessment scale, calculating ASIA motor scores, FIM, and SCIM. Hypothermia-related potential complications will be evaluated, including infection, acute respiratory distress syndrome, deep vein thrombosis, pneumonia, atelectasis, electrolyte imbalance, septicemia, cardiac abnormalities (arrhythmias), thrombocytopenia, PE and death. Hypothermic subjects will be compared with normothermic control patients. This multicenter prospective study should allow us to determine if systemic hypothermia for SCI should be a part of treatment for cervical SCI patients for whom few treatment options exist.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 31, 2017
- Source ID
- W81XWH1610756
Entities
People
- Allan D Levi
Organizations
- United States Army
- University of Miami