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NEUROPROTECTION - THERAPEUTIC HYPOTHERMIA
There is a large body of evidence that controlled modest hypothermia (cooling the body temperature) is a safe and effective neuroprotective intervention in animal models of spinal cord injury (SCI) and traumatic brain injury (TBI). In late 2009 and early 2010, Miami Project researchers published the first evidence that therapeutic hypothermia is safe to administer to humans with acute SCI. In that initial trial there was a trend for more people to recovery more function after 1 year post-injury than would normally occur spontaneously. However, there were only 14 participants in this initial trial, which is too small of a number to definitively establish efficacy. The compiled data does strongly suggest that additional trials, including multiple medical centers, should be undertaken so more information can be generated. 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.
ARCTIC is the acronym for our next clinical trial testing the safety and efficacy of therapeutic hypothermia (cooling) in SCI, Acute Rapid Cooling Therapy for Injuries of the Spinal Cord. ARCTIC will be a Phase II/III clinical trial where we will evaluate the safety of different durations of hypothermia, initiated within 6 hours post-injury, and then confirm the efficacy of the best duration. We have taken what may seem like a long time to plan this clinical trial, but for many good reasons. One, predicting whether someone has a “complete” or “incomplete” SCI within the first 6 hours is VERY difficult and unreliable. In fact, it is not reliable until after 72 hours post-injury. However, because we have such a short time window in which to intervene with hypothermia, it is a complication we must deal with. Two, this trial will involve more than 200 people with acute SCI and cost several million dollars. We have been working with the National Institutes of Health sponsored Neurologic Emergencies Treatment Trials (NETT) network for review and, hopefully, funding. Three, we have to get this right, the SCI field needs it! There have been too many “failed” Phase III clinical trials because of design issues. Drs. Michael Wang and Dalton Dietrich have been working with several experts in clinical trial design and statistics to develop the most appropriate design to capture clinically meaningful improvements yet still be responsive to unknown safety issues. If this pivotal trial gets funded and the data positively demonstrate that the benefits significantly outweigh the risks, we could change the standard of care for SCI medicine worldwide.
A great boost for research addressing therapeutic hypothermia is the development of a new journal titled Therapeutic Hypothermia & Temperature Management. This new journal will publish research studies investigating temperature sensitive mechanisms of protection or recovery after central nervous system injury. Excitedly, Dr. Dalton Dietrich, our Scientific Director, has agreed to be the Editor-in-Chief of the new journal, Dr. Helen Bramlett will be the Managing Editor, and Dr. Barth Green will be a member of the Editorial Board. They will now be able to help guide this field of research even more than ever!