Journal of Clinical Trials
Open Access

Abstract

STATA- Strategy of Transfusion in Trauma Patients: A Randomized Trial

Roseny dos Reis Rodrigues, Raphael Oliveira, Lucas Lucena, Heleno Paiva, Vinicius Cordeiro, Maria José Carmona, José Otávio Costa Auler, Edivaldo Massazo Utiyama, Klaus Gorlinger, Donat Spahn and Herbert Schöchl

Background: Trauma is a leading cause of death worldwide and massive bleeding is the main cause of death in the first 24 hours after injury. Patients with large blood volume loss should undergo the massive transfusion protocol to quickly restore the blood volume and the clotting factors that were lost during bleeding. There are two common strategies regarding transfusion therapy for multiple trauma patients with severe bleeding. The fixed ratio strategy is based on the proportional transfusion of packed red blood cells, fresh frozen plasma and platelets (fixed ratio 1:1:1). The thromboelastometry guide approach is based on the physiopathology of the trauma coagulopathy is a phenomenon that occurs in the early stages of trauma, with hyperfibrinolysis and fibrinogen consumption. Blood products are given based on viscoelastic tests. Methods/design: This study is a prospective, single-center, open-label, randomized trial. Males and females between 18 and 80 years old, with severe trauma and a high Injury Severity Score (ISS- greater or equal than 15) admitted to trauma emergency room are included. To be included, patients require is bleeding actively, with inclusion criteria’s to massive transfusion protocol. Patients are randomly allocated to one of the two strategies for massive transfusion (Group A- fixed ratio 1:1:1 or group B- thromboelastometry guided). The primary outcome is the incidence of organ dysfunction on the first, 5th, and 7th day until 28 days post. The secondary outcome are the consumption of blood products within 48 hours, the length of stay in the hospital, days without mechanical ventilation and the financial costs in both groups. Discussion: This trial was proposed to answer questions about the outcomes related to these two strategies of transfusion. This study is important because there is a lack of prospective studies with the subject proposed. Trial registration: Clinical Trial NCT02416817