The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
Konkuk University Medical Center
Seoul, South Korea
RECRUITINGCRT maximal amplitude
maximal amplitude of CRT test
Time frame: 24 hours
CK reaction time
value of r-time of CK test
Time frame: 24 hours
CK alpha angle
value of alpha-angle of CK test
Time frame: 24 hours
CRT maximal lysis
value of maximal lysis of CRT test
Time frame: 24 hours
CFF maximal amplitude
value of maximal amplitude of CFF test
Time frame: 24 hours
Hemoglobin
serum hemoglobin value
Time frame: 24 hours
packed RBC
number of unit, transfused packed RBC
Time frame: 6 hours
fresh frozen plasma
number of unit, transfused fresh frozen plasma
Time frame: 6 hours
cryoprecipitate
number of unit, transfused cryoprecipitate
Time frame: 6 hours
platelet
number of unit, transfused platelet (apheresis) or platelet concentrate
Time frame: 6 hours
seizure
incidence of postoperative seizure
Time frame: 48 hours
thromboembolism
incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Time frame: 48 hours
postoperative bleeding
amount of bleeding from surgical drain
Time frame: 48 hours
re-operation
incidence of re-operation due to postoperative bleeding
Time frame: 48 hours
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