Transfusion of modified whole blood versus blood components therapy in patients with severe trauma: Randomized controlled trial protocol (WEBSTER trial).

Abstract

Hemostatic resuscitation is a mainstay in the management of trauma patients. Factors such as blood loss and tissue injury contribute to coagulation and hemodynamic status imbalances. Hemorrhage remains a leading cause of death in trauma patients, despite advances in strategies such as damage control surgery, massive transfusion protocol, and intensive care. Conventional hemostatic resuscitation often involves a 1:1:1 ratio of red blood cells, plasma, and platelets. However, this ratio has disadvantages, especially in low-resource settings. Whole blood transfusion maintains a physiological rate of cells, clotting factors, and hemostatic properties. Advances in the whole blood elucidated a new opportunity for its implementation in civilian trauma centers. However, the effect of initial resuscitation with whole blood in trauma patients is unclear. This study aims to determine the effect of hemostatic resuscitation using whole blood on mortality and evolution of organ dysfunction in severe trauma patients compared to blood components therapy. This clinical trial attempts to resolve the debate and uncertainty of using whole blood vs. blood components. An open-label, randomized, prospective, single-center and controlled trial will be performed. Participants will be randomly assigned to receive either 3 units of whole blood or 3 units each of red blood cells and fresh frozen plasma, plus half an apheresis unit of platelets (equivalent to 3 platelet units). A second intervention of the same ratio will be administered if further transfusion is required. The primary outcome is a hierarchical composite outcome based on mortality at 28 days and the evolution of organ dysfunction. Organ dysfunction will be measured as the difference in the score between the fifth and first days of the SOFA (Sequential Organ Failure Assessment). Secondary outcomes are mortality, coagulopathy profile, intensive care unit free days, length of hospital stay, and volumes of transfusion requirements. Safety outcomes are complications related to transfusion and complications related to trauma (acute distress respiratory syndrome, pulmonary embolism, deep vein thrombosis, acute kidney injury with or without dialysis, stroke, myocardial infarction, cardiac arrest, sepsis, abdominal complications, abdominal compartment syndrome). TRIAL REGISTRATION: ClinicalTrials.gov: NCT05634109 - Whole Blood in Trauma Patients with Hemorrhagic Shock (WEBSTER).