MORGANTOWN, W.Va. – Researchers at WVU Medicine J.W. Ruby Memorial Hospital 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.
Bleeding out is the most common cause of preventable death after injury. 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.
Kcentra® (or four-factor Prothrombin Complex Concentrate [PCC]) is a Food and Drug Administration (FDA) approved drug and is currently used to reverse the effects of medications given to “thin” the blood in patients who experience bleeding and/or require surgery.
“There is evidence that Kcentra® may reduce the chance of dying in injured patients who are not on blood-thinning medications,” James Bardes, M.D., trauma surgeon at J.W. Ruby Memorial Hospital and primary investigator on the study, said.
“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 percent of patients suffering from a serious traumatic injury die. Finding a way to improve that survival rate is our highest priority here at WVU Medicine.”
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 Ruby Memorial, then Ruby 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 that makes PCC.
“The results of this study have the potential to change the way trauma patients are treated,” Dr. Bardes 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.”
The researchers are asking for feedback from the local community about this study to help determine whether the community wants them to participate in it. Those interested in providing feedback can do so by completing a brief, anonymous online survey. To complete the survey, visit www.uab.edu/medicine/cis/tap-trial-at-west-virginia.
Patients with questions about the trial can contact Bardes at email@example.com or Catherine VanMeter, Trauma research coordinator, at 304-598-4000 ext. 75424 or firstname.lastname@example.org.