NCT01060189

Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemostasis

Interventions

Type	Name	Description
DRUG	Ulinastatin
DRUG	Tranexamic Acid
DRUG	Saline Solution

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-01-01
• Completion: 2019-01-01
• First posted: 2010-02-02
• Last updated: 2019-02-05

Locations

1 site across 1 country: China