Actue Rapid Cooling for Traumatic Injuries of the Cord

PI: Michael Wang, MD - University of Miami

Status: Submitted, pending review

Traumatic spinal cord injury affects an estimated 11,000 people in the United States each year, most commonly affecting young adults in the prime of their life. Advances in the medical management of this patient population have resulted in improvements in the survivability of these injuries, with a majority of patients having a near-normal life expectancy. Thus, because of its devastating consequences but high likelihood of long-term survivability, exerts a disproportionate medical, social and economic toll. A great deal of research has been directed at identifying interventions which may mitigate the secondary mechanisms which lead to neurological worsening and impede native recovery. However, to date there have been no clinical trials definitively demonstrating the efficacy of acute interventions to improve neurological outcomes in humans with traumatic spinal cord injuries.

The NETT has proposed a randomized, controlled, multi-center study to investigate the efficacy of modest intravascular hypothermia (33.5 + 0.2° C) for improving neurological function following both complete and incomplete spinal cord injuries in humans. Significant improvement will be determined by a greater than 10 point difference between the two treatment arms in the mean change in motor score as determined at 12 month follow-up. Additional outcome measures will include ASIA sensory scores and measures of pain and disability. It is anticipated that such a study will answer the question of whether emergent intravascular cooling, a method which has shown promise in the laboratory, can improve the neurological function and independence of patients suffering from spinal cord injuries.