Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Hemostasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060189
• Other study ID #: UTI Pilot Study
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: January 2019
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemostasis

Intervention

Drug:
• Ulinastatin

• Tranexamic Acid

• Saline Solution

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative blood loss	Defined as the total volume of chest drainage postoperatively	Postoperatively
Secondary	Rate of reexploration for bleeding		Postoperatively
Secondary	Rate of major bleeding	Major bleeding is defined according to the CURE study	Perioperatively
Secondary	Transfusion of allogeneic erythrocytes	Rate of exposure and volume of allogeneic erythrocytes transfused	Perioperatively
Secondary	Transfusion of fresh frozen plasma (FFP)	Rate of exposure and volume of FFP transfused	Perioperatively
Secondary	Transfusion of allogeneic platelets	Rate of exposure and volume of allogeneic platelets transfused	Perioperatively
Secondary	Length of stay in ICU and hospital postoperatively		Postoperatively