16 Sep Traumatic Brain Injury: Out-of-Hospital Tranexamic Acid vs Placebo
MedicalResearch.com Interview with:
Susan Rowell MD, MBA, MCR
Associate Professor, Department of Surgery
Division of Trauma, Acute & Critical Care Surgery
Duke University School of Medicine
Durham, NC 27710
MedicalResearch.com: What is the background for this study?
Response: Tranexamic acid (TXA) has been increasingly used in trauma patients since publication of the CRASH-2 trial in 2010 demonstrated a survival benefit for patients at risk for traumatic hemorrhage. Subsequently, it was shown that the earlier TXA was administered, the better the outcome. There had been several small studies suggesting that TXA may also be beneficial in patients with traumatic brain injury (TBI), however, an adequate prospective randomized trial was needed.
In this trial we randomized over 1000 patients with moderate and severe TBI as early as possible after injury (by paramedics in the prehospital setting an average of 42 minutes after injury) to either a 1-gram TXA bolus followed by a 1-gram 8-hour TXA infusion (the dose typically used for trauma patients), a 2-gram TXA bolus only (a logistically easier route of administration requiring no maintenance infusion), or placebo only.
MedicalResearch.com: What are the main findings?
Response: We found no difference in long-term neurologic outcome when we compared all patients who received TXA to those who received placebo. However, our planned analyses comparing individual TXA dosing arms demonstrated that those patients who had an intracranial hemorrhage on admission CT scan who received a 2-gram prehospital TXA bolus were significantly less likely to die by 28 days after injury compared to patients who received either a 1-gram TXA bolus followed by the 1-gram 8-hour TXA infusion or those who received placebo.
Furthermore, patients who received the 2-gram TXA bolus also demonstrated improved 6-month neurologic outcome based on the Disability Rating Scale score but not based on the Extended Glasgow Outcome Scale score compared to the other two groups. Finally, there was no difference in thromboembolic complications between groups but patients who received a 2-gram TXA bolus had a higher rate of seizure-like activity.
MedicalResearch.com: What should readers take away from your report?
Response: In this trial in patients with moderate or severe TBI who were not in shock, patients who received a 2-gram TXA bolus had very different outcomes than patients who received a 1-gram TXA bolus followed by a 1-gram 8-hour TXA infusion. When combined together and compared to placebo, no difference in long-term neurologic outcome was observed. What readers should take away from this trial is that in patients with moderate or severe TBI who have an intracranial hemorrhage, a 2-gram bolus of TXA given within 2 hours of injury resulted in a significant decrease in mortality compared to patients who received either a 1-gram TXA bolus followed by a 1-gram 8-hour TXA infusion or placebo. No difference in mortality was observed comparing patients who received a 1-gram TXA bolus followed by a 1-gram 8-hour TXA infusion to placebo.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: While it appears that a 2-gram bolus of TXA administered within 2 hours of injury improves survival in patients with moderate or severe TBI and intracranial hemorrhage, it remains unclear whether this translates into improved long-term neurologic outcome. Given the concomitant increase in seizure-like activity, more research is needed to further clarify these findings.
Rowell SE, Meier EN, McKnight B, et al. Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury. JAMA. 2020;324(10):961–974. doi:10.1001/jama.2020.8958
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