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

Study Overview
=================
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.

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

Conditions
-----------------
Arthritis Knee, Spine Fusion, Prostate Cancer, Arthritis of Hip, Hepatic Cancer

Intervention / Treatment
-----------------
* Drug: TXA
* Diagnostic Test: TEG6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria patients undergoing following surgery spinal fusion surgery with more than 2 levels total hip arthroplasty total knee arthroplasty open prostatectomy hepatectomy 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized prospective multicenter non-inferior
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TXA empirical<br>Empirical Tranexamic acid (TXA) administration after the anesthesia induction | Drug: TXA<br>* Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr<br>* Other names: TXA administration;|
| Experimental: TXA TEG6-triggered<br>When LY30> 3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered | Drug: TXA<br>* Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr<br>* Other names: TXA administration;Diagnostic Test: TEG6<br>* performing thromboelastography (TEG6)<br>* Other names: thromboelastography 6;|
| Experimental: TXA TEG6-non-triggered<br>When LY30 ≦ 3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered | Diagnostic Test: TEG6<br>* performing thromboelastography (TEG6)<br>* Other names: thromboelastography 6;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT maximal amplitude | maximal amplitude of CRT test | 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure