Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Hemostasis

Treatments: Drug: Tranexamic Acid; Drug: Saline Solution; Drug: Ulinastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01060189

UTI Pilot Study

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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426 participants in 3 patient groups, including a placebo group

Ulinastatin

Experimental group

Description:

1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization

Treatment:

Drug: Ulinastatin

Tranexamic Acid

Experimental group

Description:

15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

50ml saline solution before skin incision; 50ml saline solution after neutralization

Treatment:

Drug: Saline Solution