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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulinastatin | Experimental | 1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization |
|
| Tranexamic Acid | Experimental | 15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization |
|
| Placebo | Placebo Comparator | 50ml saline solution before skin incision; 50ml saline solution after neutralization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulinastatin | Drug |
| ||
| Tranexamic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative blood loss | Defined as the total volume of chest drainage postoperatively | Postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reexploration for bleeding | Postoperatively | |
| Rate of major bleeding | Major bleeding is defined according to the CURE study | Perioperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lihuan Li, MD | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Study Chair |
| Jia Shi, MD | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32410683 | Derived | 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. |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Saline Solution | Drug |
|
| 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 |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |