Bleeding out is the most common cause of preventable death after injury. Researchers at Sanford Health 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.
Kcentra (or 4-factor Prothrombin Complex Concentrate) is a Food and Drug Administration 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,” explains Khaled Zreik, M.D., a trauma surgeon at Sanford Medical Center Fargo in North Dakota.
“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,” said Dr. Zreik. “Finding a way to improve that survival rate is our highest priority here at Sanford.”
Clinical trials with ER patients
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 approves the study at Sanford Health, then Sanford Health 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.
Complete the survey:
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,” said Paul Bjordahl, M.D., a trauma surgeon at Sanford USD Medical Center in Sioux Falls, South Dakota. “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 Fargo and Sioux Falls communities about this study to help determine whether the community wants us to participate in this study. Please consider completing a very brief anonymous survey hosted by the local study site.
Complete the anonymous survey on your thoughts about this exception from informed consent study.
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