Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Study Overview
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Brief Summary
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The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include comparing the 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
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The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, 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
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Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration

Conditions
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Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage

Intervention / Treatment
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* Drug: TXA administration
* Drug: Placebo administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass patients who provide written informed consent 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
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized prospective double-blind placebo-controlled multicenter non-inferior
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Empirical 1: TXA and Placebo administration<br>Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo administration, at LI60 < 85 % or A10< 40 mm in EXTEM of rotational thromboelastometry | Drug: TXA administration<br>* Tranexamic acid intravenous administration<br>* Other names: Tranexamic acid;Drug: Placebo administration<br>* Placebo (normal saline) intravenous administration<br>* Other names: Placebo (normal saline);|
| Active Comparator: Empirical 2: TXA administration<br>Tranexamic acid administration, regardless of the result of rotational thromboelastometry. Placebo discard, at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry | Drug: TXA administration<br>* Tranexamic acid intravenous administration<br>* Other names: Tranexamic acid;|
| Experimental: Goal-directed 1: Placebo administration<br>Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid administration at LI60 < 85 % or A10 < 40 mm in EXTEM of rotational thromboelastometry | Drug: TXA administration<br>* Tranexamic acid intravenous administration<br>* Other names: Tranexamic acid;Drug: Placebo administration<br>* Placebo (normal saline) intravenous administration<br>* Other names: Placebo (normal saline);|
| Experimental: Goal-directed 2: TXA and Placebo administration<br>Placebo administration, regardless of the result of rotational thromboelastometry. Tranexamic acid discard at LI60 ≥ 85% or A10 ≥ 40 mm in EXTEM of rotational thromboelastometry | Drug: Placebo administration<br>* Placebo (normal saline) intravenous administration<br>* Other names: Placebo (normal saline);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative bleeding | bleeding amount though chest drainage tubes during the 1st postoperative 24 hour | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative transfusion amount | amounts of transfused red blood cells, plasma, platelet and cryoprecipitate | 24 hours | 
| postoperative transfusion rate | incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions | 24 hours | 
| the lowest postoperative hemoglobin value | the nadir hemoglobin value during one postoperative days | 24 hours | 
| incidence of reoperation | incidence of reoperation due to postoperative bleeding | 1 week | 
| amount of intraoperative cell salvage | amounts of infused salvaged blood | 1 hour | 
| viscoelastic whole blood profile | values of intraoperative CT-EXTEM, CFT-EXTEM, A10-EXTEM, MCF-EXTEM, ML-EXTEM, CT-FIBTEM, CFT-FIBTEM, A10-FIBTEM, MCF-FIBTEM, ML-FIBTEM in rotational thromboelastometry | 1 hour | 
| incidence of seizure | incidence of postoperative seizure till the hospital discharge | 1 week | 
| incidence of thromboembolic complications | incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge | 1 week | 
| duration of mechanical ventilation | duration of postoperative ventilatory care | 1 week | 
| length of stays in the ICU and hospital |  | 1 week | 
| total cost | total expense paid at the discharge | 2 week | 
| incidence of taking renal replacement therapy |  | 1 week |