Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery

Study Overview
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Brief Summary
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In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.

Official Title
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Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass

Conditions
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Thromboses, Deep Vein, Tranexamic Acid Adverse Reaction

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease Written consent obtained Exclusion Criteria: Allergy or contraindication to tranexamic acid Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min) Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency) Thrombocytopenia defined as a platelet count <100,000/ml Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery Currently enrolled in another perioperative interventional study Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose group 1<br>The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation. | Drug: Tranexamic Acid<br>* Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.<br>|
| Experimental: Dose group 2<br>The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation. | Drug: Tranexamic Acid<br>* Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.<br>|
| Active Comparator: Dose group 3<br>The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation. | Drug: Tranexamic Acid<br>* Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of deep venous thrombosis | Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound | Within 7 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of new-onset thrombotic events | Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism | Within 90 days postoperatively | 
| The rate of allogeneic RBC transfusion | Allogeneic blood product includes packed red blood cell | Within 30 days postoperatively | 
| The volume of allogeneic RBC transfusion | Allogeneic blood product includes packed red blood cell | Within 30 days postoperatively | 
| Length of stay in ICU and hospital | The time interval between the end of the operation and the discharge from ICU or the hospital. | Within 90 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dose effect, tranexamic acid, deep vein thromboses