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Published On: Tue, May 27th, 2014

Human Trials To Begin on Biostasis Surgery Program

Human trials are set to begin at UPMC Presbyterian Hospital in Pittsburgh for a procedure that involves temporarily cooling the body temperature of trauma patients down to 10oC (50oF) in order to make lifesaving surgeries less time-dependent. The procedure, termed suspended animation, induced hypothermia, or biostasis, could have far reaching impacts on surgeries, particularly in trauma or emergency room situations.

Global Dispatch 200x119The theory behind the procedure is that surgeons do not always have enough time to perform an operation due to massive patient trauma, toxicology limitations of anesthesia or simple surgeon fatigue. By injecting a chilled saline (salt water) solution into patients, thereby inducing a hypothermic state, doctors can take their time with the surgery, ensuring each cut is precise and that all necessary internal treatments are performed. In more complicated procedures such as brain surgery (which can last up to 12 hours), or in situations where unforeseen complications arise, doctors may be able to cover the patient and convene to discuss the next step in the procedure as well as take any needed breaks.

In the UPMC trial, doctors will induce hypothermia in 10 trauma patients who would otherwise have fatal injuries to determine whether surgery under this suspended animation will save their life. The results will be compared to 10 control individuals who will not be able to be put into a hypothermic state due to the trauma team being unavailable. Because the procedure involves immediate life-or-death decisions, the FDA has approved the procedure to not require informed consent. The hospital has therefore put out a notice to the Pittsburgh community, notifying anyone that may be against this procedure to make their wishes known before they may end up in the hospital.

The trial comes almost 15 years after the first animal trials began in 2000, resulting in half a dozen published scientific papers from 2004 to 2006 by Dr. Hasan B. Alam and team in the journal Surgery and The Journal of Trauma. The papers detailed many aspects of the effects of induced hypothermia on a swine model, including immune response, hypothermic solution composition, and proper rate of rewarming so as not to shock the system. Surgery performed on pigs that underwent induced hypothermia survived 90% of the time, compared with 0% for the control pigs who underwent the same trauma surgery without induced hypothermia.

The only drawback is that the hypothermic state becomes toxic to the body after 2 hours, meaning the surgeons could not leave the patient overnight. Two hours though is plenty of time for trauma surgeons to perform the life saving procedures before the patient is rewarmed and brought to the general operating room. If successful, the procedure could herald in a new age of trauma surgery, where such ailments as cardiac arrest (currently less than a 10% survival rate) could be easily survivable.

Edward Marks is a PhD student at the University of Delaware.  His research involves the healing of myocardial tissue after major cardiac events using nanomedicine techniques, with the goal of pushing any advancement directly into the clinic.  Edward received his BS from Rutgers University and Masters from the University of Delaware.

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