Trauma is the leading cause of death among people under the age of 45. The most common cause of preventable death after experiencing a serious injury is extreme blood loss, which is often accompanied by clotting abnormalities. Researchers at Atrium Health and Wake Forest University School of Medicine have been invited to participate in an international research study to improve care for traumatic injuries. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival. Atrium Health and the School of Medicine have asked for the community’s input about their participation.
“The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products – as well as the use of medications to help the blood clot better – along with surgery to stop the bleeding,” says Dr. Samuel Ross, a trauma surgeon at Atrium Health and clinical assistant professor at Wake Forest University School of Medicine. “Even with these treatments, up to 30% of patients suffering from a serious traumatic injury die.
“We want to find a way to improve that survival rate,” he says. “It’s a high priority at Atrium Health.”
Lifesaving Treatment for Traumatic Injury
Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss and requiring immediate lifesaving interventions. These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time. Most patients will be unconscious, unable to speak or hear, and too sick to consent to immediate treatment or participation in the study, which is why it is vital to have the community understand the importance of the study’s impact now.
The Trauma and Prothrombin Complex Concentrate, or “TAP” trial, will evaluate the effectiveness of a Food and Drug Administration (FDA) approved medication, in addition to all standard care, used to treat injured patients predicted to require a large volume blood transfusion. The TAP trial will be conducted in about 120 leading trauma centers in several countries and will include 8,000 patients, making it the second-largest trauma trial ever conducted.
“The results of this study have the potential to change the way trauma patients are treated,” says Ross. “If we can determine that this new intervention is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”
Exception from Informed Consent
The TAP Trial is considered an Exception from Informed Consent (EFIC) study, which is a type of research for emergency care. In many life-threatening illnesses, patients are unconscious or too sick to provide written or verbal informed consent. The federal EFIC rules were developed in 1996 to allow for the waiver of obtaining and documenting informed consent for this strictly limited class of research.
Research conducted under EFIC rules encompasses research that could not otherwise be conducted because of the nature of illness or injury and holds the promise of a new treatment that is at least equal to or better than what is currently available.
According to FDA regulations, to qualify for EFIC, the research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high mortality rate. In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient.
The use of a randomized clinical trial such as this is considered the “gold standard” for determining what works best for people and typically uses treatments that must be given immediately to be effective. To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies.
Community Engagement
Before any EFIC trials are started, the U.S. government requires participating institutions to conduct a process of community consultation and public disclosure. During this process, the study is advertised in communities where the research will take place. Community members are invited to give their own thoughts and comments about the proposed study. The results of these interactions are reported to the Independent Review Board (IRB) monitoring the research.
The TAP trial researchers are asking for feedback from community members in several regions that may receive traumatic injury care at several proposed Atrium Health facilities. Please consider completing a very brief, anonymous survey hosted by the local study site. To complete the anonymous survey about this exception from informed consent study specific to each community, please visit one of these Atrium Health TAP Trial sites:
Atrium Health Carolinas Medical Center (Charlotte, North Carolina)
Atrium Health Wake Forest Baptist Medical Center (Winston-Salem, North Carolina)
Atrium Health Navicent (Macon, Georgia)
If the community feedback for the TAP trial is positive and the IRB approves the study at one or more of the proposed Atrium Health locations, then the approved medical centers will participate in this trial. Community members who do not want to participate can request a bracelet indicating this. If possible, doctors will ask patients who fit the study criteria for consent. If patients are unconscious and unable to consent, those who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet.
The trial is scheduled to begin this year and last until 2026. It is funded by CSL Behring, a global biotherapeutics leader which makes prothrombin complex concentrate, a blood clotting factor replacement product.
For more information on the TAP trial, please review the frequently asked questions. Additional information about EFIC trials can be found at the EFIC website of the U.S. Food and Drug Administration and the Code of Federal Regulations.
