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The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), 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.
Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.
Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(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.
Concerning the cessation 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 until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group ET | Experimental | Patients receiving early CABG <=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
|
| group EP | Placebo Comparator | Patients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution) |
|
| group LT | Experimental | Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
|
| group LP | Placebo Comparator | Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution) |
|
| group BT | Experimental | Patients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative blood loss(chest drainage) | on the 120th day postoperatively | |
| Incidence of major bleeding | on the 120th day postoperatively | |
| RBC Transfusion (volume and rate) | on the 120th day postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | on the 120th day postoperatively | |
| Major morbidity | The major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lihuang 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 |
|---|---|---|---|---|---|---|
| Capital Medical University affiliated Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23426385 | Derived | Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, Qi J, Li L. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013 Jun;148(6):538-47. doi: 10.1001/jamasurg.2013.1560. |
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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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|
| group BP | Placebo Comparator | Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution) |
|
| Saline | Drug | Saline served as placebo |
|
| on the 120th day postoperatively |
| Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC |
| Beijing |
| Beijing Municipality |
| 100037 |
| China |
| General Hospital of Chinese People's Liberation Army | Beijing | Beijing Municipality | 100853 | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | 350001 | China |
| Shanghai Jiaotong University affiliated Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| the Fourth Military Medical University affiliated Xijing Hospital | Xi’an | Shanxi | 710032 | China |
| TEDA International Cardiovascular Hospital | Tianjin | Tianjin Municipality | 300457 | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |