Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial - WEBSTER trial.
6 affiliations
- 1División de Cirugía de Trauma y Emergencias, Departamento de Cirugía, Fundación Valle del Lili - Cali, Colombia.
- 2Departamento de Cuidado Intensivo, Fundación Valle del Lili - Cali, Colombia.
- 3Centro de Investigaciones Clínicas, Fundación Valle del Lili - Cali, Colombia.
- 4Especialización en Cirugía General, Universidad Icesi - Cali, Colombia.
- 5Global Health, Division of Trauma and Surgery, University of Pittsburgh - Pittsburgh, PA, United States.
- 6Translational Research Lab in Critical Care Medicine, Universidad Icesi - Cali, Colombia.
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.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.
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BibTeX
@article{garcia2026statistical,
title = {{Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial - WEBSTER trial.}},
author = {Alberto Federico García and Andrés Gempeler and Edgar-Yaset Caicedo and Juan Carlos Puyana and Carlos A Ordóñez and Gustavo Adolfo Ospina-Tascón},
journal = {Critical care science},
year = {2026},
month = oct,
doi = {10.62675/2965-2774.20260116},
url = {https://europepmc.org/article/MED/42912021},
note = {CC BY},
}
RIS
TY - JOUR
TI - Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial - WEBSTER trial.
AU - Alberto Federico García
AU - Andrés Gempeler
AU - Edgar-Yaset Caicedo
AU - Juan Carlos Puyana
AU - Carlos A Ordóñez
AU - Gustavo Adolfo Ospina-Tascón
PY - 2026
DA - 2026/10/16
JO - Critical care science
DO - 10.62675/2965-2774.20260116
UR - https://europepmc.org/article/MED/42912021
AB - 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.
SN - 2965-2774
ER -