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 begins to breakdown its own clot which can become worse over time.
Increasingly, surgeons at trauma centers are using tranexamic acid to reduce the break down of clot and address this coagulopathy. It has been shown to be beneficial after arrival to the trauma center. The mechanisms responsible for this potential benefit are not known or whether giving it in the prehospital setting is beneficial. By stopping the breakdown of clot and improving the bodies ability to clot may reduce the need for blood transfusions and reduce mortality and improve outcome following traumatic injury. Starting treatment of clot break down with tranexamic in the prehospital setting, before arrival at the trauma center, might reduce bleeding earlier and might reduce death and complications after severe injury.
This study will determine the effect of infusing tranexamic acid during air medical (helicopter) transport on 30 day mortality in patients at risk of bleeding as compared to placebo. We will also examine the effects of tranexamic acid 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 abnormal clotting throughout the body).
In the Western Pennsylvania region, STAT MedEvac will enroll patients with blunt or penetrating trauma and at risk for significant hemorrhage who are being transported to a definitive care trauma center participating in the trial. Tranexamic acid will be given during flight in this study as compared to placebo. Tranexamic acid has not been available in the helicopter before, but data suggests the earlier tranexamic acid is given the better it may be and patients may survive and have better outcome. If tranexamic acid treatment proves beneficial, this study could provide a roadmap for many other emergency services to use tranexamic nationwide.
The study will be conducted over 3 years in Western Pennsylvania and in other centers. 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 should contact Meghan Buck at 412.864.1599 or email at firstname.lastname@example.org.