Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

Study Overview
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Brief Summary
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The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition. Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis. Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population. The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.

Official Title
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Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion

Conditions
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Coronary Artery Disease, Coronary Artery Bypass Graft

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-85 years undergoing primary and isolated on-pump CABG Last ingestion of clopidogrel and aspirin within 7 days preoperatively Exclusion Criteria: Previous cardiac surgery Hematocrit <33% Platelet count <100,000/ml Allergy to tranexamic acid Recruited in other studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Tranexamic Acid group<br>Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization | Drug: Tranexamic Acid<br>* Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization<br>|
| Placebo Comparator: Placebo group<br>Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization | Drug: Saline<br>* Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allogeneic erythrocyte, volume transfused | Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Allogeneic erythrocyte, percentage exposed | The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | The total volume of chest drainage from the end of the operation until the removal of the drainage tube | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Major bleeding | The incidence of major bleeding according to the CURE definition | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 
| Reoperation | The incidence of reoperation for excessive bleeding | Participants will be followed for the duration of hospital stay, an expected average of 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, Coronary Artery Disease, Coronary Artery Bypass Graft, Platelet Aggregation Inhibitors