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

Phase 4

Recruiting

• Conditions: Hepatic Cancer; Prostate Cancer; Arthritis Knee; Spine Fusion; Arthritis of Hip
• Interventions: Drug: TXA; Diagnostic Test: TEG6

• Registration Number: NCT05957822
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-16
• Study First Posted: 2023-07-24
• Study Start: 2024-02-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-12-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

• pregnancy
• refusal of allogenic blood transfusion
• taking thrombin
• history of thromboembolic and familial hypercoagulability disease
• recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
• hypersensitive to TXA
• histroy of convulsion or epilepsy
• taking hemodialysis
• history of Heparin-induced thrombocytopenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TXA empirical	TXA	Empirical Tranexamic acid (TXA) administration after the anesthesia induction
TXA TEG6-triggered	TXA	When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
TXA TEG6-triggered	TEG6	When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
TXA TEG6-non-triggered	TEG6	When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered

Primary Outcome Measures

Name	Time	Method
CRT maximal amplitude	24 hours	maximal amplitude of CRT test

Secondary Outcome Measures

Name	Time	Method
CK reaction time	24 hours	value of r-time of CK test
CRT maximal lysis	24 hours	value of maximal lysis of CRT test
fresh frozen plasma	6 hours	number of unit, transfused fresh frozen plasma
CFF maximal amplitude	24 hours	value of maximal amplitude of CFF test
seizure	48 hours	incidence of postoperative seizure
thromboembolism	48 hours	incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
postoperative bleeding	48 hours	amount of bleeding from surgical drain
CK alpha angle	24 hours	value of alpha-angle of CK test
packed RBC	6 hours	number of unit, transfused packed RBC
platelet	6 hours	number of unit, transfused platelet (apheresis) or platelet concentrate
re-operation	48 hours	incidence of re-operation due to postoperative bleeding
Hemoglobin	24 hours	serum hemoglobin value
cryoprecipitate	6 hours	number of unit, transfused cryoprecipitate

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of