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The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.
Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.
Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.
The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid group | Experimental |
|
|
| Placebo group | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Allogeneic erythrocyte, volume transfused | Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Allogeneic erythrocyte, percentage exposed | The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | The total volume of chest drainage from the end of the operation until the removal of the drainage tube | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Major bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lihuan Li, M.D. | Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital | Beijing | 100037 | China |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline | Drug |
|
|
The incidence of major bleeding according to the CURE definition
| Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| Reoperation | The incidence of reoperation for excessive bleeding | Participants will be followed for the duration of hospital stay, an expected average of 7 days |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |