Prehospital Tranexamic Acid Fails to Improve Posttrauma Function

Favorable functional outcome at six months was similar for trauma patients who received prehospital tranexamic acid versus placebo at advanced trauma facilities, despite reduced early mortality with treatment, according to new research published July 13 in the New England Journal of Medicine.

“Our trial provides new information on the quality of survival after severe trauma that is treated with tranexamic acid,” the researchers wrote.

Previous trials have examined the administration of pretranexamic acid within three hours of traumatic injury in countries lacking organized regional trauma systems. This study (PATCH-Trauma) was conducted in New Zealand, Australia and Germany, all of which have established advanced trauma systems.

The proportion of patients with favorable functional outcome at six months (the primary outcome) was comparable for those who received tranexamic acid on the scene of traumatic injury or en route to the emergency department versus those who received placebo. Favorable functional outcome was measured using the Glasgow Outcome Scale–Extended and was achieved in 53.7% and 53.5% of patients, respectively.

The researchers noted that “for every 100 patients assigned to receive tranexamic acid rather than placebo, there were approximately four extra patients alive at six months; however, approximately four extra patients were also categorized as having severe disability.”

Mortality at 24 hours after injury was lower for those who received tranexamic acid prior to hospital arrival — 9.7% with tranexamic acid and 14.1% with placebo. Mortality at six months was 19% in the tranexamic acid group and 22.9% in the placebo group.

The researchers were also interested in rates of vascular occlusive events (deep venous thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke or other arterial events). Nearly a quarter of patients in the tranexamic acid group (23.6%) had one or more vascular occlusive events compared with 19.7% in the placebo group.

In this trial, investigators enrolled adults with suspected severe traumatic injuries who they assessed as being at high risk for trauma-induced coagulopathy. The first dose of tranexamic acid or placebo had to be administered within three hours of injury (at the scene or en route). A second dose of tranexamic acid or placebo (sodium chloride solution) was administered in the hospital. Patients were randomized 1:1 and all trial personnel were blinded.

Coagulopathy risk had to be assessed prior to hospital arrival and measured using the Coagulopathy of Severe Trauma (COAST) score (0-7 points). COAST score factors include entrapment in a vehicle, systolic blood pressure of less than 100 mm of mercury (mm Hg), body temperature of less than 35 degrees Celsius, suspected pneumothorax and suspected intra-abdominal or pelvic injury. A COAST score of three or greater is considered high risk. Patients were also assessed for deep vein thrombosis using Doppler ultrasound.

Prespecified subgroups were based on age, initial score on the Glasgow Coma Scale, initial systolic blood pressure, mechanism of injury and time from injury to first dose of tranexamic acid/placebo. Investigators observed no differences between the treatment and placebo groups in any of these analyses.