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(HealthNewsDigest.com) – TUCSON, Ariz. – Uncontrolled hemorrhage (bleeding) is the primary cause of significant complications and death to traumatically injured patients. Banner – University Medical Center Tucson (BUMCT) has been selected as one of several Level 1 trauma centers in the United States to determine if a transfusion of tranexamic acid (TXA) administered in the helicopter prior to hospital arrival is more effective in saving the lives of patients requiring massive blood transfusions.
One reason for unbridled hemorrhage in patients after severe injury is early coagulopathy, a condition in which the blood’s ability to clot (coagulate) is impaired. When an injury is too severe, the body begins to breakdown its ability to clot, causing prolonged or excessive bleeding. Tranexamic acid (TXA) is an anti-fibrinolytic drug that blocks the action of plasminogen, an enzyme that dissolves blood clots. It has been used for decades to minimize blood loss in planned surgeries, control oral bleeding in people with hemophilia and treat heavy menstrual periods. (To learn more about TXA: http://en.wikipedia.org/wiki/
In 2010, a British trial involving more than 20,000 people in 40 countries showed that TXA also could significantly reduce the risk of fatal bleeding in trauma patients, potentially saving 128,000 lives each year. Military studies also have shown substantial benefits of TXA to treat wartime injury and hemorrhage. Bringing this proven treatment to the prehospital air ambulance/ helicopter and intervening sooner to those patients has real potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical outcomes and provide insight into the underlying mechanisms responsible for – and which maximize – TXA’s benefits. (STAAMP video https://www.youtube.com/watch?
Banner – UMC Tucson is the only trauma center in the Southwest involved in the trial, “Study of Tranexamic Acid During Air Medical Prehospital (STAAMP) Transport.” The study is a phase 3, multicenter, prospective, randomized, blinded, controlled interventional trial sponsored by the U.S. Department of Defense (DOD) and the Telemedicine and Advanced Technology Research Center (TATRC).
The UA Department of Surgery will receive funding to conduct the three-year clinical trial. UA trauma surgeon Gary Vercruysse, MD, associate professor of surgery and medical director of the Burn Care Program, is leading the study at Banner – University Medical Center. A total of 994 severely injured patients with blunt or penetrating trauma will be enrolled from the participating sites in the United States. Patients who qualified for the study include those admitted to Banner – University Medical Cetner Tucson with severe traumatic injuries and predicted to need a massive transfusion to survive.
For patients at risk of bleeding who are transported by air medical transport, a 1 gram bolus of prehospital tranexamic acid and in-hospital TXA dosing regimens will be compared to placebo for clinical, coagulation, inflammatory and dosing regimen endpoints.
In Helicopter Intervention:
One gram 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 different 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, professor and chief of the hospital’s Level I Trauma Center, added, “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.”
Patients 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 transport trial falls under a unique Federal Drug and Administration (FDA) regulation concerning “exception from informed consent.” Such regulations are strict and the research must meet very specific federal regulations and local Institutional Review Board review and approval. They give the physician in the trauma center the ability to enroll patients into the study even though the patients are unable to speak for themselves because of life-threatening injury or illness.
One requirement of this regulation is that the community receives education about the study. Researchers are getting the word out through newspaper as well as social media, telephone calls, and town hall meetings.
Anyone who does not want to participate in the study can request a STAAMP “opt out” wristband and one will be mailed to them. People should continue to follow their current standard for notifying medical personnel of their wishes to not receive any blood products. Your care at Banner – University Medical Center Tucson will not be affected in any way. You will continue to receive the highest standard of care, regardless of your participation.
For more information on the study visit http://surgery.arizona.edu/
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