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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
552
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
Saline served as placebo
Capital Medical University affiliated Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC
Beijing, Beijing Municipality, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Shanghai Jiaotong University affiliated Chest Hospital
Shanghai, Shanghai Municipality, China
the Fourth Military Medical University affiliated Xijing Hospital
Xi’an, Shanxi, China
TEDA International Cardiovascular Hospital
Tianjin, Tianjin Municipality, China
Postoperative blood loss(chest drainage)
Time frame: on the 120th day postoperatively
Incidence of major bleeding
Time frame: on the 120th day postoperatively
RBC Transfusion (volume and rate)
Time frame: on the 120th day postoperatively
Mortality
Time frame: 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.
Time frame: on the 120th day postoperatively
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