Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Hemostasis

Intervention / Treatment
-----------------
* Drug: Ulinastatin
* Drug: Tranexamic Acid
* Drug: Saline Solution


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulinastatin<br>1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization | Drug: Ulinastatin<br> <br> |
| Experimental: Tranexamic Acid<br>15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization | Drug: Tranexamic Acid<br> <br> |
| Placebo Comparator: Placebo<br>50ml saline solution before skin incision; 50ml saline solution after neutralization | Drug: Saline Solution<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative blood loss | Defined as the total volume of chest drainage postoperatively | Postoperatively | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ulinastatin, tranexamic acid, cardiac surgery procedures, hemostasis