Objectives

To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in participants with moderate or severe traumatic brain injury.

Background

Millions of people worldwide sustain traumatic brain injuries (TBIs). TBI is the leading cause of death and disability due to trauma. Despite this, no drug has been approved to manage acute TBI. Tranexamic acid, which prevents the breakdown of fibrin clots, has been used for decades to control bleeding. After a 2010 clinical trial demonstrated a survival benefit for patients at risk for traumatic hemorrhage who received tranexamic acid, its use expanded to treating patients with severe hemorrhagic shock. The ROC-TXA trial was initiated to examine whether tranexamic acid administered within 2 hours of injury would improve neurologic outcome in participants with TBI.

Participants

The target population included out-of-hospital individuals with blunt or penetrating TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. Participants were only eligible if the study drug could be administered within 2 hours of injury and the EMS transport destination was a participating trauma center. Participant exclusion criteria included seizure or history of seizure.

A total of 1063 participants were randomized. 345 participants were randomized to the bolus maintenance group, 373 to the bolus only group and 345 to the placebo group.

Design

ROC-TXA was a multicenter, double-blinded, randomized clinical trial. 20 trauma centers and 39 emergency medical services agencies across the US and Canada participated in the study.

Participants were randomly assigned to 1 of 3 treatment groups: 1g IV tranexamic acid bolus in the out-of-hospital setting followed by a 1-g tranexamic acid IV infusion initiated upon hospital arrival and infused over 8 hours (bolus maintenance group), 2g IV tranexamic acid bolus in the out-of-hospital setting followed by a placebo infusion (bolus only group), or IV placebo bolus in the out-of-hospital setting followed by an IV placebo infusion (placebo group). Adverse events that occurred during the initial 28 days of hospitalization were recorded.

The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid groups vs the placebo group. Secondary outcomes included 28-day mortality, 6-month Disability Rating Scale score and progression of intracranial hemorrhage.

Conclusions

Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended.

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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