Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Graft; Coronary Artery Disease
• Interventions: Drug: Saline; Drug: Tranexamic Acid

• Registration Number: NCT01596738
• Lead Sponsor: Li Lihuan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-09
• Last Update Submitted: 2012-05-09
• Study First Posted: 2012-05-11
• Last Update Posted: 2012-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Saline	1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction 2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
Tranexamic Acid group	Tranexamic Acid	1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction 2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital; 🇨🇳 Beijing, China