Fort Worth, Texas - JPS Health Network is consulting the Dallas-Fort Worth residents in a virtual community forum on Tuesday, June 6, and Wednesday, June 7, to seek their opinions regarding a local trauma research study. The study aims to explore the use of Kcentra® (or 4-factor Prothrombin Complex Concentrate), a blood clotting medication approved by the Food and Drug Administration (FDA), in reversing the effects of blood-thinning drugs given to patients who are bleeding or require surgery.
Researchers at JPS are seeking community feedback regarding their participation in the international study since bleeding out is the most common cause of preventable death after injury. The study will see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
The Trauma and Prothrombin Complex Concentrate or TAP Trial will evaluate the effectiveness of Kcentra® and all standard care in injured patients predicted to require a large volume of blood transfusion.
"There is evidence that Kcentra® may reduce the chance of death in injured patients who are not on blood-thinning medications," said Dr. Rajesh Gandhi, Medical Director of Trauma Services. "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."
The study will involve patients who have suffered a serious and potentially life-threatening injury causing significant blood loss and requiring immediate lifesaving interventions. Since these injuries occur unexpectedly, it will not be possible for most people to sign up to participate beforehand. If the community feedback is positive and an independent review board (IRB) approves the study at (Local Institution), then (Local Institution) will participate in this trial. Community members who do not want to participate can request a bracelet indicating this. If feasible, doctors will consent to patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their 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 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 who makes PCC.
"The results of this study have the potential to change how trauma patients are treated," said Dr. Gandhi. "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."
To share your thoughts on the TAP trial, please visit https://www.uab.edu/medicine/cis/tap-trial-at-jps
About JPS Health Network
The Tarrant County Hospital District, known as JPS Health Network, is a tax-supported organization serving the healthcare needs of families in Tarrant County. JPS provides adult inpatient care at John Peter Smith Hospital in Fort Worth, Texas, and offers comprehensive services including primary care, behavioral health, and pharmacy at more than 25 community locations. JPS has served as a Level I Trauma Center in Tarrant County for more than a decade. JPS is governed by an 11-member Board of Managers, whose members are appointed by the Tarrant County Commissioners Court. JPS was named the Best Hospital for America by Washington Monthly magazine and the Lown Institute in 2020, and Outstanding Healthcare System by D CEO Magazine.