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MedStar Washington Hospital Center is participating in a national study to learn whether a blood clotting medicine can help stop life-threatening bleeding in patients who have suffered a traumatic injury.
The drug, Prothrombin Complex Concentrate (PCC), has already been approved by the U.S. Food and Drug Administration (FDA) to help stop bleeding in people who take the blood thinner Warfarin.
Researchers hope to learn whether PCC works as well to stop life-threatening bleeding in patients after a car crash, fall, or gunshot or knife wound. Bleeding is the second most common cause of death among people who’ve had a traumatic injury.
PCC may make a difference, improving trauma care for people at risk of life-threatening bleeding. This study is a bit different than most because the participants have suffered traumatic injury.
Research to improve trauma care.
The Trauma and Prothrombin Complex Concentrate Trial (TAP) is organized by the Center for Injury Science at the University of Alabama at Birmingham and will be conducted at more than 100 hospitals across the U.S., including two in Washington, D.C.
When a patient with trauma comes to the emergency department, a surgeon will determine whether they are at risk for life-threatening bleeding. All patients will get high-quality care—such as procedures, surgery, and/or transfusions as needed. Those at risk of life-threatening bleeding will also get either PCC or a placebo, an identically packaged vial that does not contain medicine. No one involved in the patient’s care will know whether they got PCC or a placebo.
No additional tests or appointments are needed in the study.
By analyzing participants’ anonymized medical records, researchers hope to learn whether patients who get PCC have less bleeding than the placebo group.
Understanding exception from informed consent.
There’s an important difference between the TAP trial and traditional research. Traditionally, a process called informed consent ensures that people who might get involved in research understand the risks, benefits, and alternatives to participating. This information helps them decide whether to participate.
Because patients who may be involved in the TAP trial are at risk of life-threatening bleeding, time is of the essence. It is likely they will have unstable vital signs, be unconscious, or be in too much pain to consider the risks and benefits of participation.
This is why the TAP trial is an uncommon type of research called Exception From Informed Consent (EFIC). This limited research requires extra supervision to ensure it’s conducted correctly. At each participating hospital, a panel of experts called an Institutional Review Board oversees EFIC research and the FDA provides national oversight.
In all EFIC research, including TAP, patients or their decision makers are always informed of trial participation as soon as possible. We want to make sure our whole community knows this research is happening, so we’ve been hosting meetings and writing articles like this to help get the word out.
We want to hear from you.
EFIC research requires a phase called community consultation, in which people who could be research participants have an opportunity to learn about the study, ask questions and offer comments, or opt out in advance with medical bracelets that indicate you do not wish to participate.
MedStar Washington Hospital Center is going above and beyond to make sure as many of our neighbors as possible know about the TAP trial. We’re sensitive to concerns about consent, and we want everyone to have an opportunity to get as much information as possible.
We look forward to hearing from community members. This consultation is a critical part of our research to improve trauma care and increase survival rates for everyone.
