Trauma patients would be automatically enrolled in the study even if they are unconscious but in a life-threatening medical condition
SCOTTSDALE, Ariz. — Oct. 4, 2023 — HonorHealth Research Institute is consulting the people of Scottsdale and Phoenix about whether to lead a local trauma research study to investigate a blood clotting agent as a treatment for trauma patients who are bleeding to death.
Bleeding out is the most common cause of preventable death after injury. The Research Institute is asking the community for input about whether it should participate in an international study to see if a blood clotting drug, given soon after arrival in the emergency room, can improve survival.
Community members may complete a brief, anonymous survey about this exception from informed consent by going to: https://www.uab.edu/medicine/cis/tap-trial-at-honorhealth
Kcentra® (or 4-factor Prothrombin Complex Concentrate, PCC) is an FDA-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 John Kepros, M.D., medical director of trauma services at HonorHealth Scottsdale Osborn Medical Center and the principal investigator for the TAP Trial for HonorHealth Research Institute.
“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. Kepros. “Finding a way to improve that survival rate is our highest priority here at HonorHealth Research Institute.”
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 HonorHealth hospitals, then the Institute will participate in this trial.
Community members who do not want to participate can request a bracelet indicating that they opt out of the TAP Trial. To request a bracelet, please visit: https://www.uab.edu/medicine/cis/tap-trial-at-honorhealth/opt-out-of-trauma-research
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 at 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 in 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,” Dr. Kepros 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.”