Prostate Cancer Clinical Trial
Official title:
Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
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.
Status | Recruiting |
Enrollment | 148 |
Est. completion date | January 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Konkuk University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Medical Center | Asan Medical Center, Korea Health Industry Development Institute, Soon Chun Hyang University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CRT maximal amplitude | maximal amplitude of CRT test | 24 hours | |
Secondary | CK reaction time | value of r-time of CK test | 24 hours | |
Secondary | CK alpha angle | value of alpha-angle of CK test | 24 hours | |
Secondary | CRT maximal lysis | value of maximal lysis of CRT test | 24 hours | |
Secondary | CFF maximal amplitude | value of maximal amplitude of CFF test | 24 hours | |
Secondary | Hemoglobin | serum hemoglobin value | 24 hours | |
Secondary | packed RBC | number of unit, transfused packed RBC | 6 hours | |
Secondary | fresh frozen plasma | number of unit, transfused fresh frozen plasma | 6 hours | |
Secondary | cryoprecipitate | number of unit, transfused cryoprecipitate | 6 hours | |
Secondary | platelet | number of unit, transfused platelet (apheresis) or platelet concentrate | 6 hours | |
Secondary | seizure | incidence of postoperative seizure | 48 hours | |
Secondary | thromboembolism | incidence of postoperative myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction | 48 hours | |
Secondary | postoperative bleeding | amount of bleeding from surgical drain | 48 hours | |
Secondary | re-operation | incidence of re-operation due to postoperative bleeding | 48 hours |
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