Impact of different preferred functional outcomes on the results of the pre-hospital antifibrinolytics for traumatic coagulopathy and hemorrhage (PATCH-trauma) trial.

RATIONALE: Ordinal endpoints offer more detailed outcome assessment than mortality, though some disabilities may be considered worse than death by patients.

OBJECTIVES

To evaluate how different Glasgow Outcome Scale - Extended (GOS-E) hierarchical structures affect effect estimation in the PATCH-Trauma trial.

METHODS

This post-hoc analysis of the PATCH-Trauma trial compared pre-hospital tranexamic acid (TXA) to placebo in severely injured patients at risk of acute traumatic coagulopathy. The study included patients with complete 6-month outcomes. Using generalized pairwise comparisons, researchers analyzed the 8-point GOS-E, ICU length-of-stay, and thromboembolic complications. Results were reported using win ratio (WR) statistics, with values above one favoring TXA. The analysis explored GOS-E with mortality rankings adjusted based on different outcomes being considered worse than death.

MAIN

RESULTS

The study included 1107 patients (546 placebo, 561 TXA). Original GOS-E results showed a neutral WR (1.03; 95 % CI 0.90-1.19). When death was considered preferable to progressively less impaired functionality (from vegetative state to upper moderate disability), the WR decreased to 0.86 (95 % CI 0.75-1.00).

CONCLUSION

The assessment of TXA therapy's efficacy and safety may vary depending on scenarios where certain functional outcomes are considered worse than death. This analytical approach could inform functional outcome assessment in future acute care trials.