CURRENT PHASE: Enrollment Complete
- Dr. Philip Spinella, MD
- Dr. Grant Bochicchio, MD, MPH
Washington University School of Medicine Physicians have completed their clinical research study at Barnes-Jewish Hospital that aimed to improve care for trauma patients.
The news release pertaining to study results can be accessed here: Link
The research study was funded by The United States Department of Defense This study was different from other research studies because it involved patients who were not able to give consent and the treatment had to be given within 2 hours of injury. In order to conduct this study without initial consent, we were required to inform and consult with the public through community outreach before this study was approved or started. Qualifying subjects/patients were enrolled into the study without their consent unless they were wearing a visible OPT OUT bracelet that was provided FREE to interested community members by the TAMPITI study team.
Regulations created by the Federal government, (21 Code of Federal Regulations §50.24) state the conditions under which an exception from informed consent in emergency situations is allowed so that research can be done even when consent is not possible because of the nature and extent of the patient’s injuries.
Patients were able to OPT out of the study by wearing the free, Washington University-specific bracelet that specified “OPT OUT TAMPITI”. This method was not perfect since it may be lost in traumaIf a family member was immediately present in the Emergency Department during the patient’s admission, the study team spoke to the family member to obtain permission to enroll the patient into the study after providing a brief background of the study including the risks and benefits of participating.
Once enrolled, researchers informed the legally authorized representative (LAR) or proxy decision maker (PDM) of the research study to get consent for further blood samples and data collection. The LAR or PDM were allowed to refuse further blood and data collection or withdraw the patient from the research study. In the event that an LAR or PDM chose to withdraw the subject/patient from the research study, they were counseled on the necessity for safety assessments to be conducted by the study team. If they still chose to withdraw the patient from study participation, they were reminded that information already obtained up until withdraw will be maintained by the study team, but no further study procedures will be performed.
Bleeding is the most avoidable cause of death in trauma patients. Up to one-third (1/3) of severely injured trauma patients experience coagulopathy (a condition in which the blood’s ability to clot is impaired), and as a result, many die from rapid and sudden blood loss. Current treatments (blood product transfusion, etc.) are often ineffective and new options are being sought. Tranexamic Acid (TXA), a drug that is already FDA approved for certain bleeding conditions, such as hemophilia and heavy menstrual bleeding, but not yet FDA approved for severe bleeding in trauma, is a NEW option we are planning to study here at Barnes-Jewish Hospital/Washington University in St. Louis.
The purpose of this study was to evaluate the effects of TXA on the immune system, pharmacokinetics (the way the body absorbs and breaks down the medication), as well as TXA’s safety and effectiveness in severely injured trauma patients.
Current Standard of Care
The current standard of care for trauma patients is to give sterile saline (salt water) through the veins on the way to the Emergency Room. When the patients arrive at the hospital, they are evaluated and are given blood products if they are bleeding.
The TAMPITI TRIAL (Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury) took place at Barnes-Jewish Hospital from March of 2016 through September of 2017.
The Study Design
Patients 18 years and older admitted to the Barnes-Jewish Hospital Emergency Room with a traumatic injury (e.g. car crash, gunshot wound, etc.) and were ordered by doctors to receive at least 1 blood product and/or require immediate transfer to the operating room AND were able to receive the study drug within 2 hours from time of injury were included in the study. Once enrolled, they assigned at random to receive a placebo (inactive substance, salt water) in their IV, or dose 1 of an experimental drug, (TXA, 2 gram dose in their IV), or dose 2 of an experimental drug (TXA, 4 gram dose in their IV). After the IV treatment was given (placebo or TXA dose1 or TXA dose 2), each group had blood samples collected at various time points. Blood samples and clinical information were collected throughout the hospital stay up to 30 days after injury.
What TXA Does:
TXA speeds up the process of blood clotting which, in the end, may improve survival.
Risks of TXA
Less Likely/Less Common:
- Gastrointestinal disturbances (nausea, vomiting, diarrhea)
- Allergic dermatitis
- Hypotension (low blood pressure)
- Allergic reaction
- Thromboembolic events (including but not limited to blood clots in the arms or legs, stroke, heart attack, blood clots in the lungs)
- Convulsions or seizure
- Visual impairment
- Chromatopsia (objects appear to be colored)
In addition to these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this study.
Why is research important to emergency medicine?
Watch this video to gain a better understanding of how research and clinical trials help make improvements for patients everywhere. Note: This video, used courtesy of the National Institutes of Health (NIH) and the Neurological Emergencies Treatment Trials (NETT) Network, is intended to inform communities about the importance of emergency research in general. Participants in the video are not necessarily endorsing any specific clinical trials.
- Cap, A.P., et al., Tranexamic acid for trauma patients: a critical review of the literature. J Trauma, 2011. 71(1 Suppl): p. S9-14.
- Brohi, K., et al., Acute traumatic coagulopathy: initiated by hypoperfusion: modulated through the protein C pathway? Ann Surg, 2007. 245(5): p. 812-8.
- Hess, J.R., et al., The coagulopathy of trauma: a review of mechanisms. J Trauma, 2008. 65(4): p. 748-54.
- Pusateri, A.E., et al., Tranexamic Acid and Trauma: Current Status and Knowledge Gaps with Recommended Research Priorities. Shock, 2012.
- collaborators, C.-t., et al., Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant hemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet, 2010. 376(9734): p. 23-32.
- Morrison, J.J., et al., Military Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg, 2012. 147(2): p. 113-9.
- Levy, J.H., Antifibrinolytic therapy: new data and new concepts. Lancet, 2010. 376(9734): p. 3-4.
- Brohi, K., et al., Acute coagulopathy of trauma: hypoperfusion induces systemic anticoagulation and hyperfibrinolysis. J Trauma, 2008. 64(5): p. 1211-7; discussion 1217.
- Raza, I., et al., The incidence and magnitude of fibrinolytic activation in trauma patients. J Thromb Haemost, 2012.