Hemorrhage remains the most common cause of preventable death after injury. 4-Factor Prothrombin Complex Concentrate is currently approved for urgent reversal of Vitamin K-dependent coagulation factor deficiency (due to warfarin) in patients experiencing acute major bleeding or in need of urgent surgical/invasive procedures. The product contains factors II, VII, IX, and X, as well as Protein C and Protein S, and thus may be useful in facilitating hemostasis in trauma patients with major bleeding. There is good preclinical evidence, and an increasing number of observational studies, suggesting a potential role for 4-Factor Prothrombin Complex Concentrate in this clinical setting.

CSL Behring, in collaboration with the Center for Injury Science at the University of Alabama at Birmingham, is currently seeking potential enrollment sites for a large, prospective, multicenter, multinational, randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the use of 4-factor PCC in patients with acute major bleeding associated with traumatic injury.