Study of Tranexamic Acid during Air Medical Prehospital (STAAMP) Trial.
Phase 3 Multi-center, Prospective, Randomized, Blinded, Controlled Interventional Trial
Start Date: August 2015-2018
Enrolling: This clinical trial will enroll 994 patients. Tucson enrollment is likely to be approximately 120 patients
Principal Investigator: Gary Alec Vercruysse, MD, Associate Professor of Surgery
Interests: Burn care, burn education and economics, hemorrhagic shock
Sponsor: Department of Defense (DOD) & Telemedicine and Advanced Technology Research Center (TATRC)
ClinicalTrials.gov: More Information
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.
Surgeons at trauma centers are using tranexamic acid (TXA) to reduce the breakdown of clot and address this coagulopathy; however, 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 body’s ability to clot may reduce the need for blood transfusions and reduce mortality and improve outcome following traumatic injury. Starting treatment of clot breakdown with TXA in the prehospital setting, before arrival at the trauma center, might reduce bleeding earlier and might reduce death and complications after severe injury. Click her to learn more about TXA.
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 TXA 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 Southern Arizona we will enroll patients with blunt or penetrating trauma and at risk for significant hemorrhage who are being transported to Banner-University Medical Center Tucson. TXA will be given during flight in this study as compared to placebo. Data suggests the earlier TXA 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 Southern Arizona and in other centers.
In Helicopter Intervention:
1gm of TXA or placebo will be infused. Prehospital providers and trauma center staff will be blinded to all treatment given.
Trauma Center Intervention:
Enrolled patients who received TXA will undergo a second randomization to one of three protocols: repeat TXA dosing, standard dosing or abbreviated dosing.
“This study vindicates the safety and efficacy of massive transfusion, with fewer patients dying early on from uncontrolled hemorrhage,” said Dr. Vercruysse. “We are both honored and excited to have been chosen by the Department of Defense to be a part of the next logical step in this process, using TXA to help prevent unnecessary bleeding.”
Peter Rhee, MD, said,
“Injury from trauma is one of the leading causes of death in the United States, especially in young people. Uncontrolled hemorrhage from traumatic injuries is the leading cause of potential preventable death in the United States.”
You Have the Right to “Opt Out:”
Because patients with traumatic injury may be unconscious and unable to give consent to participate in the study, the STAAMP trial falls under a unique Federal Drug and Administration (FDA) regulation concerning "exception from informed consent."
Anyone not wishing to be in the study can request a STAAMP “opt out” wristband and one will be mailed to them. People should continue to follow their current medical directives for notifying medical personnel of their wishes to not receive any blood products.
If you choose not to participate in this study, your care at BUMCT will not be affected in any way. You will continue to receive the highest standard of care regardless of your participation.
To request an opt-out bracelet, please call Laurel Rokowski, RN at 520-626-2876 or email Laurel@surgery.arizona.edu.
An Institutional Review Board responsible for human subject’s research at The University of Arizona reviewed this research project and found it to be acceptable, according to state and federal regulations and University policies designed to protect the rights and welfare of participants in research.