Researchers at Reading Hospital are asking for community input to determine participation in an international study. Uncontrolled bleeding resulting in severe blood loss is the most common cause of preventable death after injury. The study would assess whether 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 that is currently used to reverse the effects of medications given to “thin” the blood, for patients who experience bleeding or require surgery. The Trauma and Prothrombin Complex Concentrate or TAP Trial will evaluate the effectiveness of Kcentra®, in addition to our standard care, for injured patients predicted to require a large-volume blood transfusion. “There is evidence that Kcentra® may reduce the chance of dying for injured patients not taking blood-thinning medications,” explains Adrian Ong, MD, a trauma surgeon at the hospital.
“The standard treatment for injured patients with a bleeding emergency involves the transfusion of various blood products, and medications to improve blood clotting, along with surgery needed to stop the bleeding. Even with these treatments, up to 30% of patients with serious traumatic injury may die,” said Dr. Ong. “Finding a way to improve that survival rate is our highest priority here at Reading Hospital.”
Patients who participate in the study will have suffered a serious injury, causing significant blood loss, and requiring immediate lifesaving interventions. Injuries of this nature occur unexpectedly, preventing most people from enrolling ahead of time. Patients will often be unconscious, unable to speak or hear, and too sick to consent to immediate treatment or participation in the study. When administering life-saving measures to control active bleeding during an emergency, doctors may enroll patients in the study during treatment.
Reading Hospital will participate in this trial if community feedback is positive and an independent review board (IRB) approves the study. Doctors will acquire consent from patients who fit the study criteria when feasible. If consent is not possible, those patients will automatically be enrolled if they are not wearing an opt-out bracelet. Community members who do not wish to participate can request an “Opt Out of Trauma Research” wristband.
“The results of this study have the potential to change how trauma patients are treated,” said Dr. Ong. “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 TAP trial will be conducted in approximately 120 leading trauma centers across several countries involving 8,000 patients - making it the second-largest trauma trial ever conducted. The trial, which will begin in early 2023 and last until 2026, is funded by CSL Behring, a global biotherapeutics leader that makes PCC.
The researchers are seeking feedback from the Berks County community to help determine public interest in this study. Please consider completing a brief anonymous survey to voice your perspective.
To share your thoughts about this exception from informed consent (EFIC) study, please go to:
Community members are also invited to attend a virtual meeting to learn more about trauma research and the TAP trial. Attendees are eligible to receive a $25 gift card.
To participate in a virtual meeting, please join using the following links:
About Reading Hospital
Reading Hospital is the flagship, Magnet Recognized, acute care hospital of Tower Health. Located in West Reading, Pa., Reading Hospital is a 697-bed hospital that is home to many top-tier specialty care centers, including Reading HealthPlex, McGlinn Cancer Institute, Miller Regional Heart Center, Emergency Department, Level I Trauma Center and Beginnings Maternity Center, which houses the region's only Level III Neonatal Intensive Care Unit (NICU). With more than 1,000 physicians, specialists, and advanced practice providers across 49 locations, Reading Hospital has been recognized for its quality outcomes and clinical expertise across service lines. It is listed as one of America's 50 Best Hospitals for three consecutive years. For more information, visit towerhealth.org.