Pre-hospital Air Medical Plasma (PAMPer) Trial
Thank you for your interest in the Pre-hospital Air Medical Plasma (PAMPer) Trial.Back to Top
Why This Study Is Important
Although advances in the care of the severely injured patient have occurred over the past decade, the most acute threat to severely injured patients is uncontrolled hemorrhage (bleeding). This bleeding results in significant early death and the development of complications such as multiple organ failure. One reason for uncontrolled hemorrhage is the early failure of blood clotting (coagulopathy) after severe injury. Essentially, if the injury is too large, the body runs out of the factors to form blood clots to stop the bleeding.
Increasingly, surgeons at trauma centers are using early transfusion of blood components to address this coagulopathy. Early transfusions can lower mortality and reduce the total amount of blood transfusion required. Starting treatment of coagulopathy in the pre-hospital setting (before arrival at the trauma center), might lower blood component transfusion requirements even more and might reduce death and complications after severe injury even further. Plasma (a blood product) contains many clotting factors and can be used to treat bleeding patients.Back to Top
About the Study
This study will determine the effect of infusing two units of AB (universal donor) plasma during air medical (helicopter) transport on the 30-day mortality in patients with hemorrhagic shock as compared to standard medical care. We also will examine the effects of plasma on other clinical outcomes (clotting measurements on arrival to trauma center, total blood transfusion requirements during the first 24 hours, the development of multiple organ failure, hospital-acquired infection, acute lung injury (ALI) and transfusion related acute lung injury (TRALI)). If plasma treatment proves beneficial, this study could provide a roadmap for many other emergency services to use plasma nationwide.
The study will be conducted over four years at several established trauma centers throughout the country. The University of Pittsburgh will serve as the coordinating center for this multi-center clinical trial. The University of Louisville Hospital Trauma Center, working with the University of Louisville Department of Surgery, will be one of the participating trauma centers. Other participating centers include Case Western University (Cleveland, OH), University of Louisville, University of Tennessee (Knoxville, TN), University of Texas Southwestern (Dallas, TX) and Vanderbilt University (Nashville, TN).
This study will be conducted under an Exception from the Requirement for Informed Consent for Emergency Research because the patients to be enrolled will be those who have life-threatening bleeding and severe shock and are unable to provide their own consent. In this trial, the treatment must be started immediately (in the helicopter en route to the trauma center), before family will be able to be contacted.
Since this study will be conducted under the exception-from-informed consent process, community consultation and public notification will be performed. If you wish to comment on this study, please contact us.
Community members who do not wish to participate in this research study can obtain a bracelet to opt out by contacting the Department of Surgery PAMPer (plasma) Study Office at 502.852.7637, writing to Plasma Study at the University of Louisville Department of Surgery (550 S. Jackson St., Louisville KY 40292), or by sending an email to Laura Trachtenberg, Research Coordinator at email@example.com.Back to Top