Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
426
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
Postoperative blood loss
Defined as the total volume of chest drainage postoperatively
Time frame: Postoperatively
Rate of reexploration for bleeding
Time frame: Postoperatively
Rate of major bleeding
Major bleeding is defined according to the CURE study
Time frame: Perioperatively
Transfusion of allogeneic erythrocytes
Rate of exposure and volume of allogeneic erythrocytes transfused
Time frame: Perioperatively
Transfusion of fresh frozen plasma (FFP)
Rate of exposure and volume of FFP transfused
Time frame: Perioperatively
Transfusion of allogeneic platelets
Rate of exposure and volume of allogeneic platelets transfused
Time frame: Perioperatively
Length of stay in ICU and hospital postoperatively
Time frame: Postoperatively
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