What is the purpose of this study?
We are doing this study to see if giving tranexamic acid (TXA) early in the course of treatment would help lower the death rate of severely injured patients that lose a lot of blood (hypovolemic shock). There is some information that suggests that severely injured people who are given TXA soon after arriving at the hospital have improved survival.
What is shock?
Shock can occur when there is massive loss of blood and a dangerously low blood pressure. When shock occurs internal organs don't receive enough oxygen and have difficulty functioning. After a traumatic injury, hemorrhage is responsible for over 35% of pre-hospital deaths and over 40% of deaths within the first 24 hours.
Why is this study important?
To try and improve the survival of patients during and after shock. To better understand the impact TXA has on the treatment and management of patients in shock following severe injuries.
What is the current standard of care?
In the helicopter patients routinely receive:
What are the standard of care limitations?
Excessive fluids and blood products can cause:
What is Tranexamic Acid?
This study involves the use of an investigational drug called tranexamic acid (TXA). "Investigational" means that the drug has not yet been approved by the U.S. Food & Drug Administration (FDA) for the use in trauma patients who are bleeding. It has been approved by the FDA for treating patients that are hemophiliacs (a rare group of people whose blood does not clot properly) and patients during dental procedures. TXA is commonly used for the treatment of other disorders that are not currently approved by the FDA. Some of these are to limit blood loss in patients undergoing cardiac (heart), orthopedic (bone) surgery, and trauma. The use of TXA in this manner is referred to as "off label".
How is this study designed?
Severely injured trauma patients determined to be in shock, (blood pressure less than or equal to 90) at the accident scene, will be randomized (assigned by chance, like flipping of a coin) to receive either the study drug or placebo (tranexamic acid or salt water) while on the helicopter enroute to University Hospital. Subjects will have an equal chance of receiving either TXA or salt water. This is a double-blinded study which means neither the subject nor the AirLIFE crew/study team will know which medication is being given. However, those taking care of the subject can find out which treatment is being given in the case of a medical emergency.
How long will the study last?
The study will be conducted for approximately three years. Individual participation in this study will last no more than 30 days.
Who will be included in the study?
Patients who are severely injured and have a high risk of bleeding will be included in this study. They must be at least 18 years old and in shock.
Who will be excluded from the study?
Patients who will not be enrolled in the study include those who:
What are the potential benefits of Tranexamic Acid?
There is the potential to stop the bleeding by helping the blood clot.
What are the potential risks of Tranexamic Acid?
Some of the side effects (risks) that have been reported in patients receiving TXA include:
How will consent be obtained?
In most, if not all cases, patients will not be able to provide informed consent to be in this study because of their injuries. Patients eligible for this study will be enrolled using the exception from informed consent.
What is an exception from informed consent?
Exception from informed consent is including people in research without first having their agreement or consent. Usually, only people who give their consent or whose next of kin give consent, are included in research. An exception from the informed consent requirement may be granted in emergency situations making is possible to conduct research even when consent is not possible due to the nature of the patient's injuries. Regulations established by the federal government specify the conditions under which research can be done with an exception from consent.
What if patients don't want to participate in this study?
Patients, and their legally authorized representatives or family members, will be notified at the earliest opportunity. A patient may withdraw or be withdrawn from the study at any time. Those who do not want to participate in the study can wear a special bracelet to exclude themselves. Contact firstname.lastname@example.org or call 800-316-8484 and ask for a member of the research team.
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Brian Eastridge, MD, UTHSCSA Department of Surgery, 7703 Floyd Curl Drive, San Antonio, TX 78229-3900.
Questions or comments? Phone 800-316-8484 or