St. Croix EMS & Rescue has been participating in a national study to determine if a medication called transexamic acid (TXA) can improve outcomes for patients who experience a traumatic brain injury since 2014. The study is testing if this medication can help prevent brain damage by reducing intracranial bleeding from the life threatening injury.
St. Croix EMS along with other local EMS agencies were asked by Region’s Hospital to participate in this national study. Other EMS agencies include Lakeview EMS, the St. Paul Fire Department and HealthEast Medical Transportation.
“Over the past 30 years there have been few advancements in the treatment of traumatic brain injuries,” said RJ Frascone, MD, medical director of Regions Hospital Emergency Medical Services department. “Smaller trials have suggested that TXA may provide these patients with better outcomes, and we hope that this larger study will help advance the treatment of these injuries.”
TXA is an FDA approved medication that is used to control bleeding in the body, specifically for patients with a high risk of bleeding during dental procedures and surgeries. This study will help determine the effectiveness of TXA in the treatment of traumatic brain injuries by comparing the outcomes of nearly 1,000 patients nation-wide.
EMS providers are an important community partner in this study since they are the first to respond to a trauma. Participating EMS agencies will immediately enroll patients with a traumatic brain injury in the study if they are being transported to the Regions-Gillette Level I Trauma Center. Patients will randomly be assigned to one of three groups:
- Group 1 which will receive 1 gram of TXA in the ambulance and another 1 gram at the hospital
- Group 2 which will receive 2 grams of TXA in the ambulance and a placebo at the hospital
- Group 3, a control group, which will receive a placebo in the ambulance and at the hospital
All other care and treatment remain the same.
Due to the severity of traumatic brain injuries, patients are unlikely to be conscious and able to give consent to participate in the study. Because of this, the HealthPartners’ Institutional Review Board has made an exception to the requirement of receiving consent from patients to be enrolled in the study.
Anyone who wishes to opt out of the study can do so by contacting Regions Hospital’s Critical Care Research Center. Individuals will receive a “TXA Research Opt Out” bracelet they must wear to ensure that they will not be enrolled in the study if they experience a traumatic brain injury.
Regions Hospital and participating EMS agencies are educating the community about the study and their ability to opt out through community consultations and public awareness efforts.
The side effects and risks associated with TXA are believed to be minimal. In rare cases patients who received too much of the medication experienced disturbances with their eyesight, nausea and/or seizures. None of these symptoms have been present in patients who have received the dosage used in this study (2 grams). Patients’ blood pressure may drop causing an increased risk of death if the medication is delivered too quickly. To prevent this, the medication has been diluted and is given over an extended period of time. Other symptoms associated with TXA include increased risk of blood clots, allergic reactions and skin irritation.
For more information about the study, or to request an opt out bracelet please call (651) 254-5303.