Although advances in the care of the severely injured patient have occurred over the last 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 like 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 prehospital 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.
This study will determine the effect of infusing 2 units of AB (universal donor) plasma during air medical (helicopter) transport on 30 day mortality in patients with hemorrhagic shock as compared to standard medical care. We will also 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)).
In this region, STAT MedEvac will enroll patients with blunt or penetrating trauma and hemorrhagic shock who are being transported to a definitive care trauma center participating in the trial. STAT MedEvac already carries red blood cells for transfusion in these patients. Plasma will be added in this study. Plasma has not been available in the helicopter before, because there are many logistical issues related to coordinating between helicopters and the blood bank. 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 4 years in Western Pennsylvania and in other centers where affiliations with local blood bank institutions exist. The University of Pittsburgh will serve as the coordinating center for this multi-center clinical trial.
This study will be conducted under an Exception from the Requirement for Informed Consent for Emergency Research because patients will be enrolled who are in extremis (life-threatening bleeding and shock), and the treatment must be started immediately (in the helicopter enroute to the trauma center).
Because patients to be enrolled in this study will be unable to give informed consent, this study will be conducted under the exception-from-informed consent process, which includes community consultation and public notification. 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 Meghan Buck at 412.864.1599 or email at email@example.com.