Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Not Applicable

Completed

• Conditions: Hemostasis
• Interventions: Drug: Saline Solution; Drug: Ulinastatin; Drug: Tranexamic Acid

• Registration Number: NCT01060189
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-01
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-02
• Last Update Posted: 2019-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline Solution	50ml saline solution before skin incision; 50ml saline solution after neutralization
Ulinastatin	Ulinastatin	1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization
Tranexamic Acid	Tranexamic Acid	15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization

Primary Outcome Measures

Name	Time	Method
Postoperative blood loss	Postoperatively	Defined as the total volume of chest drainage postoperatively

Secondary Outcome Measures

Name	Time	Method
Rate of reexploration for bleeding	Postoperatively
Rate of major bleeding	Perioperatively	Major bleeding is defined according to the CURE study
Transfusion of allogeneic erythrocytes	Perioperatively	Rate of exposure and volume of allogeneic erythrocytes transfused
Transfusion of fresh frozen plasma (FFP)	Perioperatively	Rate of exposure and volume of FFP transfused
Transfusion of allogeneic platelets	Perioperatively	Rate of exposure and volume of allogeneic platelets transfused
Length of stay in ICU and hospital postoperatively	Postoperatively

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC; 🇨🇳 Beijing, Beijing, China