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Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with
Alberto Federico García1,2, Andrés Gempeler3, Edgar-Yaset Caicedo3,4
1División de Cirugía de Trauma y Emergencias, Departamento de Cirugía, Fundación Valle del Lili - Cali, Colombia.
Background:
Hemostatic resuscitation with modified whole blood is an alternative to balanced blood-component therapy for trauma patients with hemorrhagic shock, with potential efficacy and logistical advantages. The WEBSTER trial was designed to compare these interventions in patients with trauma hemorrhagic shock.
Methods:
Single-center, open-label, parallel-group randomized clinical trial comparing whole blood with blood components in adults with trauma hemorrhagic shock.
Primary Outcome:
hierarchical composite of all-cause 28-day mortality and SOFA score during the first 5 days after randomization. We will estimate treatment effects using a win-ratio analysis that prioritizes mortality. Primary analysis follows the intention-to-treat principle; secondary analyses in as-treated and per-protocol populations are planned. Secondary outcomes include mortality at additional time points, organ dysfunction metrics, coagulation parameters, transfusion requirements, and adverse events.
Results:
Primary outcome analyses will report win ratios, and secondary outcomes will be analyzed with hypothesis tests or regression time-to-event models; 95% confidence intervals will accompany all estimates. We do not plan formal adjustment for multiplicity because the outcomes share the same underlying construct. All outcomes will be interpreted in the context of the overall pattern of results.
Conclusion:
This statistical analysis plan prespecifies transparent methods to assess the effect of whole blood versus blood-component therapy in trauma patients. The hierarchical framework, complementary sensitivity analyses and comprehensive interpretation are intended to provide a robust and clinically meaningful assessment of whole blood effects.
