Researchers Notify Community On Blood Clot Agent Study
Bleeding out is the most common cause of preventable death after injury. Researchers at the University of Nebraska Medical Center and Nebraska Medicine are notifying the community on their involvement in an international study and how the community can opt out, if they do not wish to participate. 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,” said Kevin Kemp, MD, assistant professor in UNMC’s Department of Surgery, trauma surgeon at Nebraska Medicine and local principal investigator on the study.
“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,” Dr. Kemp said. “Finding a way to improve that survival rate is our highest priority here at the med center.”
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. An independent review board (IRB) will review the community feedback before UNMC and Nebraska Medicine 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,” Dr. Kemp said. “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.”
Researchers are asking for feedback from the Omaha community about 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, go to the TAP Trial at Nebraska website.
The community also is invited to join a virtual community forum discussing the TAP Trial. Forums will be hosted via ZOOM on:
Thursday, Oct. 5 at 1:30 p.m. CST
Thursday, Oct. 5 at 2 p.m. CST
Attendees will have a chance to speak with the physician leading the trial, ask questions and learn about trauma research. Visit the TAP Trial at Nebraska website for more information about the study including links to the community forums.
Questions? Contact Debra Bergman, clinical research coordinator, at 402-559-2127 or dabergma@unmc.edu.