Maryland Shock Trauma seeks community consent on blood plasma study

Many patients taken to the University of Maryland's Shock Trauma Center in Baltimore cling to life, barely able to breathe, much less consent to participate in a medical trial, a reality that makes trauma research extremely difficult.

With life-saving advances so hard to identify, researchers at Shock Trauma now hope to get around that problem — and answer one of trauma medicine's vexing questions — by declaring nearly everyone a potential test subject.

The Baltimore hospital is one of 12 trauma centers around the country aiming to use a controversial bureaucratic tool to bypass individual consent and conduct the type of large-scale medical experiment that has proved elusive in the messy, life-and-death specialty of trauma care.

When the trial is finished sometime in 2015, researchers hope to finally answer the question of how best to transfuse blood products into a patient who is bleeding to death.

Until that answer surfaces, every accident victim, gunshot victim or other severely bleeding patient in the Baltimore area could become a test subject. Anyone who does not want to participate would need to wear an armband, announcing their intention to opt out.

Funded by the Army, the study seeks to determine the proper ratio of blood products that an emergency transfusion patient should receive. Patients brought into trauma centers would be randomly placed into groups, each given a different mixture.

The study's leaders point out that all of the blood products used — red blood cells, plasma, platelets — are approved by the U.S. Food and Drug Administration and used routinely in trauma rooms. Because treatments vary so broadly among doctors and hospitals, none of the treatments being studied is vastly different from what a patient might receive randomly anyway.

"The process of community consultation has gone through rigorous FDA review," said Dr. Thomas Scalea, head of Maryland Shock Trauma Center and principal investigator in Baltimore. "I think it is vital that we do these studies. I could be putting you at risk right now because I don't know the answer to what works best."

The FDA adopted rules in the 1990s allowing hospitals to consult with the community before conducting medical experiments for those situations when seeking patient consent isn't realistic. Community consultation furthers research on human subjects in life-threatening situations where decisions on treatment are made quickly, according to the FDA.

While the rule is not new, medical ethicists still debate its use. Some argue people should have the choice whether to participate in trials that could harm, or even kill them, no matter how slim the chances.

A study sponsored by the National Heart Lung and Blood Institute testing use of a salt solution in trauma patients without consent was shut down in 2009 because patients appeared to die more quickly and the treatment seemed to offer no health benefit.

"Can you have rules that say we're all research subjects unless we're not?" asked George J. Annas, a Boston University bioethicist and critic of community consultation. "Consent is really important."

Annas and other bioethicists said the multistate shock trauma study that includes Maryland is not as troubling because it does not involve experimental treatments. But they still question the concept of using community consultation to bypass individual consent for medical research.

"This is taking two accepted things we know work and seeing which one works best," said Daniel O'Connor, a research scientist at the Johns Hopkins Berman Institute of Bioethics. "This is not experimental. It's not like injecting Coca-Cola in subjects to see what works."

The study will look specifically at what ratio of plasma to platelets to red blood cells should be used by hospitals when transfusing blood into patients with severe injuries. One group of patients will receive one unit of plasma and platelets for every unit of red blood cells. Another group will receive one unit of plasma and platelets for every two units of red blood cells.

Trauma hospitals around the country use different ratios and studies on which works best are inconclusive. The military uses the 1:1:1 mix and has reported anecdotal success from the battlefield.

The 1:1:1 ratio also gives doctors the closest approximation of a unit of whole blood, which is used rarely for transfusions in developed countries. Donated blood is instead broken into components so doctors can prescribe for patients the components they need, each of which has different characteristics.

Red blood cells, for instance, transport oxygen from the lungs, and are prescribed often to replace lost blood. Platelets help blood to clot. Plasma carries blood proteins that also aid in the clotting process.

While it has become more common and many doctors argue it has saved lives, the use of plasma in transfusions is itself controversial. In particular, studies have linked plasma to increased risk of acute lung injury, or respiratory distress after the transfusion. The lung disorder is one of the more common causes of transfusion-related deaths and at the very least lands most patients on a ventilator.

"It's one of those things that is a double-edged sword," said Dr. Elliott R. Haut, a trauma surgeon at Johns Hopkins. "Certainly it saves lives when it is needed. If your blood is not clotting right and if you need plasma there is absolutely no question about it. It can save your life. It also brings around extra risks."