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Anesthetics

Empirical Tranexamic acid (TXA) administration after the anesthesia induction

When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered

When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered

TEG6

Tae-Yop Kim

Wooseul Lee

Tae-yop Kim, M.D, PhD

Tae-Yop Kim, MD PhD

Tae-Yop Kim, MD, PhD

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.

randomized prospective multicenter non-inferior

Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

number of unit, transfused fresh frozen plasma

number of unit, transfused cryoprecipitate

number of unit, transfused platelet (apheresis) or platelet concentrate

incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery	NCT05957822	Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hi... Hepatic Cancer	TXA TEG6	19 Years -	Konkuk University Medical Center
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery	NCT05957822	Arthritis Knee Spine Fusion Prostate Cancer Arthritis of Hi... Hepatic Cancer	TXA TEG6	19 Years -	Konkuk University Medical Center

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