Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

NCT ID: NCT01596738

Last Updated: 2012-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid group

1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction

2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction

2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Lihuan

OTHER

Sponsor Role: lead

Responsible Party

Li Lihuan

Professor and director of the department of anesthesiology and critical care, NCCD, PUMC & CAMS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lihuan Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS

Locations

Cardiovascular Institute and Fuwai Hospital

Beijing, , China

Countries

China

Other Identifiers

Fuwai2008

Identifier Type: -

Identifier Source: org_study_id