TRAUMOX2 Trial: Restrictive vs Liberal Oxygen in Trauma Patients
The article describes the TRAUMOX2 trial, which investigated the use of tranexamic acid in adult patients who had suffered moderate to severe traumatic brain injury. Patients included in the study had a Glasgow Coma Scale score between 3 and 12, showed evidence of bleeding inside the skull on a CT scan, and could be treated within three hours of their injury.
Participants were randomly assigned to receive either tranexamic acid or a placebo. The tranexamic acid was administered as a one gram bolus over ten minutes, followed by a one gram infusion over eight hours. The primary objective was to assess if tranexamic acid improved neurological outcomes, defined as a modified Rankin Scale score of zero to two, at six months post-injury. Secondary outcomes included overall mortality and various functional measures.
The trial found no significant difference in good neurological outcomes at six months between the tranexamic acid group and the placebo group for the overall study population. There was also no significant difference in the overall death rate between the two groups.
However, the study observed that patients treated with tranexamic acid had a lower proportion of intracranial lesion expansion, meaning the bleeding inside the skull was less likely to worsen, compared to the placebo group.
A specific analysis of a subgroup of patients with severe traumatic brain injury, those with a Glasgow Coma Scale score between three and eight, indicated a potential improvement in good neurological outcomes and a trend towards reduced death rates in the tranexamic acid group. This was a subgroup finding and not the primary outcome for the entire study population.
The trial also reported no increase in thrombotic complications, such as ischemic stroke, heart attack, pulmonary embolism, or deep vein thrombosis, in patients who received tranexamic acid. This suggests the drug was safe for use in this patient group.
In conclusion, the TRAUMOX2 trial did not demonstrate a significant improvement in neurological outcomes with early tranexamic acid administration for the overall population of moderate to severe traumatic brain injury patients with intracranial hemorrhage. Nevertheless, it did reduce the expansion of brain lesions and showed a possible benefit in the most severely injured patients, warranting further investigation in this specific subgroup. The drug was determined to be safe in this context.
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