ACUTE CARE RESEARCH
Improving on standard treatments for life-threatening conditions is an ethical imperative. The use of a randomized clinical trial is the "gold standard" for determining what works best for people. Likewise, the “gold standard” for maintaining individual rights of citizens is to ask for informed consent from persons prior to participation in a clinical trial.
INFORMED CONSENT IN EMERGENCY SITUATIONS
In emergent medical situations, a participant or their representative may be unable to provide informed consent in the customary fashion prior to treatment. Some patients are too sick to consent to immediate treatment.
For example, in trauma or in cardiac arrest, participants will either be in a semi-conscious or unconscious state when they are enrolled in research studies. Life-supporting interventions must be given immediately in the field to save their life.
Therefore, some acute care research studies are conducted under federal regulations that allow an “exception from informed consent.” For treatments that must be given immediately to be effective, exception from informed consent research is considered appropriate by federal regulatory bodies and many ethicists who study this field. In exception from informed consent trials, citizens receive standard treatment in addition to research treatment. To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies.
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)).
Emergency air medical transport vehicles 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. 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 where affiliations with local blood bank institutions exist. The University of Pittsburgh will serve as the coordinating center for this multi-center clinical trial. Participating sites include - MetroHealth Medical Center/Case Western Reserve University, University of Louisville, University of Pittsburgh, University of Tennessee Health Science Center, University of Texas Southwestern Medical Center, and Vanderbilt University.
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 extreme (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.