Researchers at Vanderbilt University Medical Center are considering participation in an international study to examine if a blood-clotting medication given to adults with major bleeding or in need of urgent surgery or an invasive procedure can improve survival.
Bleeding out is the most common cause of preventable death after injury. Kcentra or 4-factor prothrombin complex concentrate (PCC) is a drug approved by the Food and Drug Administration (FDA) currently used to reverse the effects of medications given to “thin” the blood. PCC contains clotting factors. It helps the body to form blood clots and stop bleeding.
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 Jill Streams, MD, assistant professor of Surgery and TAP Trial site investigator at VUMC.
“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,” said Mayur Patel, MD, MPH, chief of the Division of Acute Care Surgery. “But even with these treatments, up to 30% of patients suffering from a serious traumatic injury die. Finding a way to improve that survival rate is our highest priority here at Vanderbilt University Medical Center.”
Patients enrolled in the TAP 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. Most patients will be unconscious, unable to speak or hear, and too sick to give permission (also known as consent) for immediate treatment or participation in the study.
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. Individuals who do not want to participate can request a bracelet indicating this.
If the community feedback is positive and an independent review board (IRB) approves the study at VUMC, then the Medical Center will participate in this trial. An IRB oversees research conducted on human subjects to ensure the rights, welfare and safety of the individuals who enroll in the study are protected. Before any research procedures can begin, the IRB must review and approve the study protocol, the informed consent document(s), as well as any other study materials.
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 began in early 2023 and will last until 2026. The TAP trial 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 Patel. “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 residents of Nashville and the surrounding community to help determine whether the community wants VUMC to participate in this study.
To complete a brief, anonymous survey to share your thoughts about this exception-from-informed-consent study, go to https://uab.co1.qualtrics.com/jfe/form/SV_8rnIKZZlwIsokVo
Below are opportunities to speak with the VUMC physicians leading this trial, ask questions and learn about trauma research through Zoom community forums.
Open community forums:
Oct. 19, at 10 a.m. https://uab-mc.zoom.us/j/86182088298
Oct. 26, at 11 a.m. https://uab-mc.zoom.us/j/89009857913
Focus groups for trauma survivors, ICU survivors and supporting families:
Oct. 19, at 4 p.m. https://uab-mc.zoom.us/j/84692371727
Oct. 26, at 4 p.m. https://uab-mc.zoom.us/j/81937634843
For more information:
