Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Coronary Artery Bypass Graft
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100037
    • Cardiovascular Institute and Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid group; Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction; Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization	Drug: Tranexamic Acid; Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction; Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
Placebo Comparator: Placebo group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Li Lihuan
• Investigators: Principal Investigator: Lihuan Li, M.D., Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 5, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Estimate): May 11, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Platelet Aggregation Inhibitors; Tranexamic Acid; Coronary Artery Bypass Graft
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Fuwai2008