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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, China
The incidence of deep venous thrombosis
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Time frame: Within 7 days postoperatively
The rate of new-onset thrombotic events
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
Time frame: Within 90 days postoperatively
The rate of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Time frame: Within 30 days postoperatively
The volume of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Time frame: 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.
Time frame: Within 90 days postoperatively
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