University of Maryland Shock Trauma will use community consent to test whether cooling the bodies of gunshot victims in cardiac arrest can help save lives
When a victim of a gunshot or stab wound arrives at an emergency room in cardiac arrest, doctors have mere minutes to open the patient's chest and wrap their hands around the heart to get it pumping again.
The odds are against survival: About 95 percent die.
Researchers at the University of Maryland Shock Trauma Center want to buy a few more moments for these patients.
Their idea: Drop the body temperature to 50 degrees, preserving the heart, brain and other organs while they fix any injuries, and then warming and reviving the patient before everything shuts down. They have won funding from the Army to investigate.
"The biggest thing in this situation is, once the heart stops no oxygen or blood flows to vital organs," said Dr. Samuel Tisherman, a principal investigator of the study and professor of surgery at the University of Maryland School of Medicine. "Every second, every minute counts in terms of vital organs now suffering because there is no oxygen."
But researchers face a challenge: The patients on whom they would test the method are unconscious and so badly injured they can't consent to experimental treatment — as patients are when they arrive at Shock Trauma.
So they're turning to a novel and sometimes controversial process known as community consultation, in which the researchers will try to get broad community support, in lieu of permission from individuals.
The Shock Trauma team are asking healthy members of the community if they would be open to the treatment. People who do not want to participate can opt out by wearing a special bracelet.
Over the next several weeks, researchers are planning to visit community meetings, church events and other gatherings to sell people on the study. They will also run newspaper advertisements and run a website about the study.
Shock Trauma has had success with other studies using community consultation. In 2012, it participated in a multihospital study sponsored by the Army to explore what blood mixture is best for transfusions during trauma.
The study of 680 severely injured patients found that those who received a mix of one unit of red blood cells, one unit of platelets and one unit of plasma were less likely to die from blood loss. Hospitals across the country are adopting that standard.
Dr. Thomas M. Scalea, the chief physician at Shock Trauma, said community consultation is a fair way to protect patients while also refining treatments.
"This could really save a lot of lives," Scalea said. "In any of the complicated trauma trials, unless you do this, you will just never know what works best."
The Food and Drug Administration adopted rules in the 1990s to allow hospitals to use community consultation in some circumstances to secure consent.
The agency says the approach furthers research on human subjects in life-threatening situations where decisions on treatment are made quickly.
Medical ethicists still debate its use. Some argue that people should have the choice whether to participate in trials that could harm or even kill them.
A study sponsored by the National Heart Lung and Blood Institute that involved the use of a salt solution in trauma patients without their consent was shut down in 2009 because the treatment seemed to offer no health benefit, and the patients appeared to die more quickly.
But some bioethicists say that experiments on some life-saving treatments would be impossible without the option of community consent.
"Community consent can be very important because, as in this situation, there are people in emergency situations and we need to improve our knowledge so that we have the best treatments," said Dr. Robert Klitzman, director of the master's degree program in bioethics at Columbia University. "We want to improve the science and do the research."
Klitzman said that it needs to be true community consent, which he said means actively engaging the population, and having more than two people show up to a meeting. He said particular care should be taken with African-Americans — such as many of the gunshot victims Shock Trauma will be studying — who have been exploited in the past for medical research.
"You need to make it as robust a consultation process as one can," Klitzman said. "Especially given the sensitivity in vulnerable communities."
There is also a concern that scientists could pitch the study, even unintentionally, in a biased way, or in the most positive light, said Nancy Kass, deputy director for bioethics and public health at the Johns Hopkins Berman Institute of Bioethics.
Still, she said, there are many benefits to the practice. And she pointed out layers of protections for patients, including ethics reviews of research studies before they are conducted.
"Research with people who are incapacitated, who are unable to provide consent for themselves, is really between a rock and a hard place," Kass said. "On the one hand, none of us wants big-time experimental research to go forward without the person saying it is OK. But if we required that standard for all research, we are never able to make progress in treating people in emergency situations."
Patients who suffer a cardiac arrest after a penetrating trauma, such as a gunshot or stab wound, will be eligible to enroll in the Shock Trauma study when standard resuscitation techniques do not work.
To cool the body, a large volume of cold saline solution will be pumped directly into the bloodstream. Once the source of the bleeding has been found and repaired, a heart-lung bypass machine will be used to restore blood circulation and warm the body back up.
The researchers emphasized that the study will follow strict federal guidelines. Any studies using community consultation are reviewed carefully by the FDA and require approval and oversight of an institutional review board at the University of Maryland throughout the investigation. The FDA doesn't say specifically what amounts to sufficient community consultation.
The researchers hope to complete community consultation by the end of the year and present the findings to the institutional review board to seek regulatory approval to begin enrolling patients.