Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

NCT ID: NCT01060189

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2019-01-31

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.

Conditions

Hemostasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ulinastatin

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

Group Type: EXPERIMENTAL

Ulinastatin

Intervention Type: DRUG

Tranexamic Acid

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

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline Solution

Intervention Type: DRUG

Interventions

Ulinastatin

Intervention Type: DRUG

Tranexamic Acid

Intervention Type: DRUG

Saline Solution

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

SHI Jia

Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lihuan Li, MD

Role: STUDY_CHAIR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Jia Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Locations

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, China

Countries

China

References

Zhang P, Lv H, Qi X, Xiao W, Xue Q, Zhang L, Li L, Shi J. Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up. J Cardiothorac Surg. 2020 May 14;15(1):98. doi: 10.1186/s13019-020-01144-9.

Reference Type: DERIVED

PMID: 32410683 (View on PubMed)

Other Identifiers

UTI Pilot Study

Identifier Type: -

Identifier Source: org_study_id