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In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose group 1 | Experimental | The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation. |
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| Dose group 2 | Experimental | The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation. |
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| Dose group 3 | Active Comparator | The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of deep venous thrombosis | Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound | Within 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of new-onset thrombotic events | Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism | Within 90 days postoperatively |
| The rate of allogeneic RBC transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Shi, M.D. | Contact | 86 10 88322467 | shiandypumc@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Shi, M.D. | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences， Fuwai Hospital | Beijing | 100037 | China |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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The allocation is masked for the participant, care provider, investigator and outcomes assessor.
Allogeneic blood product includes packed red blood cell
| Within 30 days postoperatively |
| The volume of allogeneic RBC transfusion | Allogeneic blood product includes packed red blood cell | Within 30 days postoperatively |
| Length of stay in ICU and hospital | The time interval between the end of the operation and the discharge from ICU or the hospital. | Within 90 days postoperatively |