Critical care science
Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial - WEBSTER trial
By García AF, Gempeler A, Caicedo EY and 3 others.
Abstract
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.