TAP TRIAL AT Sanford Health (ND)
TAP Trial Termination CSL Behring has made the difficult decision to end the Trauma and Prothrombin Complex Concentrate (TAP) Trial of Kcentra® (BE1116_3006), for trauma patients with major bleeding. The trial began in early 2023 and was originally scheduled to last until 2026. As the TAP trial progressed, it became clear that the trial would take several years longer than originally planned, and results would not be available in a reasonable amount of time. It is possible that the study results may not have been relevant in several years because of changes in trauma care. Importantly, the decision to stop the trial was not due to any safety or quality concerns. Several reasons would have caused the trial to take longer than expected:
By the time the trial ended it had already enrolled just under 1,400 patients, making it one of the largest studies of trauma patients ever completed. The TAP study team will analyze the information collected, including a safety analysis and make the results public when available. The study results will be available on www.ClinicalTrials.gov and will be published in a peer-reviewed medical journal. The summary of the study results will be available at www.trialsummaries.com when the final study results are completed. If you obtained an Op-out bracelet indicating you did not wish to be enrolled in this clinical trial, you no longer need to wear the bracelet. We would like to extend our sincere gratitude to each community that agreed to conduct this important trial, which will hopefully contribute to advancing trauma care for years to come. Special thanks are owed to the participants and families who took part in the TAP trial. |