Clinical trial NCT01060189: Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery
Official title: Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemostasis
Keywords: ulinastatin
tranexamic acid
cardiac surgery procedures
hemostasis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative blood loss
timeFrame: Postoperatively
Secondary outcomes:
measure: Rate of reexploration for bleeding
timeFrame: Postoperatively
measure: Rate of major bleeding
timeFrame: Perioperatively
measure: Transfusion of allogeneic erythrocytes
timeFrame: Perioperatively
measure: Transfusion of fresh frozen plasma (FFP)
timeFrame: Perioperatively
measure: Transfusion of allogeneic platelets
timeFrame: Perioperatively
measure: Length of stay in ICU and hospital postoperatively
timeFrame: Postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Lihuan Li, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Jia Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.