Fibrinogen Versus Fresh Frozen Plasma on the Patients’ Outcome with Hemorrhagic Shock Induce Chronic Diseases Caused by Multiple Trauma: A Randomized, Double-blinded, Clinical Trial Study

Abstract

Objectives: The current study aimed to investigate the effect of fibrinogen compared to fresh frozen plasma (FFP) on outcomes of patients with traumatic hemorrhagic shock (THS). Methods: In this double-blind RCT study, traumatic hemorrhagic shock patients with chronic diseases referred to the emergency department (ED) were evaluated. Patients were randomly divided into three equal groups; The first group received fibrinogen concentrate (70 mg/kg), the second group was treated with FFP, and the third group received crystalloid. Transfusion of FFP and packed red blood cells (PRBC) was in a 1:1 ratio. The need for admission in intensive care units, PRBC transfusion units, multiple organ failure, hospitalization days, and mortality rate were compared in both groups. Results: In total, 45 patients were studied. The number of red blood cells (RBCs) transfused in patients treated with crystalloid, FFP, and Fibrinogen was 2.93, 2.37, and 2, respectively, which was statistically significant (P = 0.03). Two patients (13.3%) in the Fibrinogen-treated group, 4 (26%) in the FFP group, and 2 in the control group had multiple organ failure (P = 0.5). The incidence of sepsis was significantly higher in the FFP-treated group. In addition, mortality was significantly higher in patients who received crystalloid (46.7%) (P = 0.13). Conclusions: This study demonstrated that treating patients with fibrinogen concentrate was associated with a decreased number of pRBC transfusion units and mortality. Therefore, management of traumatic patients with fibrinogen concentrate not only can improve the outcomes but also declines patients’ exposure to allogeneic blood products.