The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
84
Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
thromboelastography (TEG6)
Normal saline injection
Konkuk University Medical Center
Seoul, South Korea
Soi Lee
Seoul, South Korea
CRT maximal amplitude
maximal amplitude of CRT test
Time frame: 24 hours
CK reaction time
r-time of CRT test
Time frame: 24 hours
CK alpha angle
alpha angle of CRT test
Time frame: 24 hours
CRT maximal lysis
maximal lysis of CRT test
Time frame: 24 hours
CFF maximal amplitude
maximal amplitude of CFF test
Time frame: 24 hours
Hemoglobin
the lowest hemoglobin value before transfusion
Time frame: 6 hours
packed RBC
transfused fresh frozen plasma
Time frame: 6 hours
fresh frozen plasma
transfused fresh frozen plasma
Time frame: 6 hours
cryoprecipitate
transfused cryoprecipitate
Time frame: 6 hours
platelet
transfused platelet (apheresis) or platelet concentrate
Time frame: 6 hours
seizure
postoperative incidence of seizure
Time frame: 48 hours
thromboembolism
preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Time frame: 48 hours
postoperative bleeding
bleeding from surgical drain
Time frame: 48 hours
re-operation
re-operation due to postoperative bleeding
Time frame: 48 hours
intraoperative bleeding
amount of intraoperative bleeding
Time frame: 4 hours
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