Arthritis Knee, Arthritis of Hip, Hepatic Cancer, Prostate Cancer, Spine Fusion
Conditions
Keywords
bleeding, viscoelastic test, tranexamic acid, transfusion, thromboembolism, fibrinolysis, seizure
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.
Interventions
Tranexamic acid injection 8-10mg/kg
performing thromboelastography (TEG6)
Sponsors
Study design
Intervention model description
randomized prospective multicenter non-inferior
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRT maximal amplitude | 24 hours | maximal amplitude of CRT test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-operation | 48 hours | incidence of re-operation due to postoperative bleeding |
| CK reaction time | 24 hours | value of r-time of CK test |
| CK alpha angle | 24 hours | value of alpha-angle of CK test |
| CRT maximal lysis | 24 hours | value of maximal lysis of CRT test |
| CFF maximal amplitude | 24 hours | value of maximal amplitude of CFF test |
| Hemoglobin | 24 hours | serum hemoglobin value |
| postoperative bleeding | 48 hours | amount of bleeding from surgical drain |
| fresh frozen plasma | 6 hours | number of unit, transfused fresh frozen plasma |
| cryoprecipitate | 6 hours | number of unit, transfused cryoprecipitate |
| platelet | 6 hours | number of unit, transfused platelet (apheresis) or platelet concentrate |
| seizure | 48 hours | incidence of postoperative seizure |
| thromboembolism | 48 hours | incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction |
| packed RBC | 6 hours | number of unit, transfused packed RBC |
Countries
South Korea