CURRENT PHASE: Enrollment Complete
Dr. Philip Spinella, MD
Dr. Grant Bochicchio, MD, MPH
Washington University School of Medicine Physicians are conducting a clinical research study at Barnes-Jewish Hospital aimed to improve care for trauma patients. The research study is sponsored by The United States Department of Defense and is currently enrolling.
This study is different from other research studies because it involves patients who cannot give consent and the treatment must be given within 2 hours of of injury. In order to conduct this study without initial consent, we must inform and consult with the public through community outreach before this study will be approved or started. Subjects/patients may be enrolled into the study without their consent unless they have a visible OPT OUT bracelet that is FREE and provided 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 may OPT out by wearing a free, Washington University specific bracelet that specifies "OPT OUT TAMPITI". This method is not perfect since it may be lost in trauma. It is the recommendation that patients always wear their OPT OUT bracelet to maximize the ability for the research team to understand the patient's wishes. OPT OUT Registration Form
If a family member is immediately present in the Emergency Department during the patient's admission, the study team will ask the family member for 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 will inform 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 can refuse further blood and data collection or withdraw from the research study. In the event that an LAR or PDM chooses to withdraw the subject/patient from the research study, they will be counseled on the necessity for safety assessments to be conducted by the study team. If they still choose to withdraw the patient from study participation, they will be 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 is 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) will take place at Barnes-Jewish Hospital in the Fall of 2015 through Spring of 2017 (specific dates to be determined).
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 are ordered by doctors to receive at least 1 blood product and/or require immediate transfer to the operating room AND are able to receive the study drug within 2 hours from time of injury will be included in the study. Once enrolled, they will be chosen 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 is given (placebo or TXA dose1 or TXA dose 2), each group will have blood samples collected at various time points. Blood samples and clinical information will be 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.
TAMPITI Trial Flyer