More than two years ago, NFL player and former Miami Hurricane Kevin Everett suffered a spinal cord injury and many believed he would never walk again. Everett was given a hypothermic treatment, the introduction of a cold saline solution that is thought to decrease damage to the spinal cord, while being transported to the hospital. It was a treatment Everett’s doctor learned about through the cutting-edge research pioneered by scientists at The Miami Project.
A team led by Allan Levi, M.D., Ph.D., professor of neurological surgery, clinical researcher at The Miami Project and chief of the neurospine service at Jackson Memorial Hospital, published their findings in this month’s issue of Neurosurgery.
“Our study included 14 participants and dealt with the most serious cases of cervical spinal cord injury in the acute setting and has shown that the treatment is safe and improved outcomes compared to historical outcomes for similar injuries without cooling,” said Dr. Levi. “We feel these results should encourage other institutions to take a closer look at the use of modest hypothermia in acute spinal cord injury cases so we can quickly and safely determine if this should be used more widely.”
Most recent clinical reports have focused on the use of cooling for head injury, stroke, and cardiac arrest, but until now there was no clinically relevant data to support its use for spinal cord injuries and no established standards of care. Much of the pre-clinical investigative data, pioneered by The Miami Project and Miller School researchers, has revealed that the treatment is not only safe, but can be extremely neuroprotective, which means that it can result in a decrease in the severity of injury and an increase in function.
Years of extensive laboratory experience under the supervision of Dr. Dalton Dietrich at The Miami Project, and through other research groups, provided the impetus to take the therapy to humans. The clinical protocols were created by Miami Project / University of Miami clinicians and researchers and currently the University of Miami/Jackson Memorial Medical Center is the only institution in the world conducting regimented hypothermia treatment and follow up for patients with acute spinal cord injury.
The Neurosurgery paper followed a manuscript published by Dr. Levi and colleagues in the Journal of Neurotrauma in March 2009 that dealt with the techniques and time frames to be used in the procedure. The papers represent the largest modern study in the administration of modest hypothermia and demonstrated that the use of systemic intravascular cooling was safe, with a similar number of complications as the control group, and provided the much needed baseline data in terms of safety and window of opportunity for cooling acutely injured patients.
The compiled data strongly suggest that additional trials, including multiple medical centers, should be undertaken so more information can be compiled. With a multi-center trial, the ability to enroll a larger number of participants is drastically increased and determination of the benefits of treatment is accelerated.
Dr. Levi, holding both an M.D. and Ph.D., has a perspective into the problem of spinal cord injury research and treatment that not many can boast. He spent a great deal of his career in the laboratory as a researcher obtaining his Ph.D. and his extensive experience as a neurosurgeon allows him to create and direct his research staff to conduct studies that apply to humans in real world situations. “The benefit of seeing the clinical issues faced by spinal cord injured patients and their doctors allows us to develop clinically relevant studies and ensure discoveries are directed at solving the problems associated with the spinal cord injury population,” added Dr. Levi.