Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Anti-Inflammatory Agents; Hemostatics; Tranexamic Acid; Urinastatin

Criteria

Inclusion Criteria:

• Atrial or ventricular septum defect patients requiring cardiac surgery with CPB

• Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB

• Coronary artery disease patients requiring coronary revascularization surgery with CPB

Exclusion Criteria:

• Non-primary cardiac surgery

• Definite liver or renal dysfunction

• Disorder in coagulation function

• Allergy

• Pregnancy or lactation

• Disabled in spirit or law

• Fatal conditions such as tumour