Journal Article

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

Young, Paul J., Mitra, Biswadev, Maegele, Marc, Burns, Brian, Gartner, Dashiell C., Zampieri, Fernando G., Gruen, Russel L., McArthur, Colin J., Forbes, Andrew B., Bernard, Stephen A.

2026

Overview

Ordinal endpoints offer more detailed outcome assessment than mortality, though some disabilities may be considered worse than death by patients. To evaluate how different Glasgow Outcome Scale - Extended (GOS-E) hierarchical structures affect effect estimation in the PATCH-Trauma trial. 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. 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). 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. [Display omitted] •PATCH-Trauma reanalysis showed different outcomes when death was preferred over severe disability•TXA win ratios declined when death was preferred over functional outcomes, suggesting potential harm•Patient preferences about death vs disability may impact how clinical trial using hierarchical endpoints should be interpreted

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Adult / Antifibrinolytic agents / Antifibrinolytic Agents - therapeutic use / Blood Coagulation Disorders - drug therapy / Blood Coagulation Disorders - etiology / Blood Coagulation Disorders - mortality / Clinical trials / Emergency Medical Services / Female / Glasgow Outcome Scale / Hemorrhage - drug therapy / Hemorrhage - etiology / Hemorrhage - mortality / Hierarchical endpoints / Humans / Length of Stay - statistics & numerical data / Male / Middle Aged / Mortality / Patients / Preferences / Sensitivity analysis / Thromboembolism / Tranexamic acid / Tranexamic Acid - therapeutic use / Trauma / Traumatic brain injury / Win ratio / Wounds and Injuries - complications / Wounds and Injuries - drug therapy / Wounds and Injuries - mortality