Northeast Georgia Medical Center (NGMC) is consulting the people of Northeast Georgia whether to lead a local trauma research study to investigate a blood clotting agent as a treatment for trauma patients who are bleeding to death.
Bleeding out is the most common cause of preventable death after injury. Researchers at NGMC are asking for community input on whether they should participate in an international study. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
Kcentra® (or 4-factor Prothrombin Complex Concentrate) is a Food and Drug Administration (FDA) approved drug and is currently used to reverse the effects of medications given to “thin” the blood, for patients who experience bleeding and/or require surgery.
The Trauma and Prothrombin Complex Concentrate or TAP Trial will evaluate the effectiveness of Kcentra®, in addition to all standard care, in injured patients predicted to require a large volume blood transfusion. “There is evidence that Kcentra® may reduce the chance of dying in injured patients who are not on blood-thinning medications,” explains Timothy Stevens, MD, a trauma surgeon at NGMC.
“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. But even with these treatments up to 30% of patients suffering from a serious traumatic injury die,” said Stevens. “Finding a way to improve that survival rate is our highest priority here at NGMC.”
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. If the community feedback is positive and an independent review board (IRB) approves the study at NGMC then NGMC will participate in this trial. Community members who do not want to participate can request a bracelet indicating this. If feasible, doctors will consent patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet.
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 trial will begin between early 2023 and last until 2026, and is funded by CSL Behring, a global biotherapeutics leader which makes PCC.
“The results of this study have the potential to change the way trauma patients are treated,” said Stevens. “If we can determine that Kcentra® is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”
The researchers are asking for feedback from the NGMC community about this study to help determine whether the community wants us to participate in this study. Please consider completing a very brief anonymous survey hosted by the local study site. To complete the anonymous survey on your thoughts about this exception from informed consent study, please go to nghs.com/tap-study.
About Northeast Georgia Health System
Northeast Georgia Health System (NGHS) is a non-profit on a mission of improving the health of our community in all we do. Our team cares for more than 1 million people across the region through four hospitals and a variety of outpatient locations. Northeast Georgia Medical Center (NGMC) has campuses in Gainesville, Braselton, Winder and Dahlonega – with a total of more than 750 beds and more than 1,200 medical staff members representing more than 60 specialties. Learn more at www.nghs.com.