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Rivaroxaban, an inhibitor of clotting factor Xa, is associated with an annual major bleeding rate of 3.6%. A specific reversal agent is not yet licensed, but factor X−containing prothrombin complex concentrates (PCCs) and the fibrinolysis inhibitor tranexamic acid have been suggested to control rivaroxaban-associated hemorrhages.
To determine whether a 4-factor-PCC or intravenous tranexamic acid can limit rivaroxaban-induced bleeding, investigators conducted an industry-supported, randomized, double-blind, parallel-group study involving 147 healthy volunteers who received rivaroxaban (20 mg twice daily) for 3 days. PCC, tranexamic acid, or saline was administered 4 hours after the rivaroxaban dose on day 4, followed by punch skin biopsies an…