Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596738
• Other study ID #: Fuwai2008
• Status: Completed
• Phase: N/A
• First received: May 5, 2012
• Last updated: May 9, 2012
• Start date: October 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
• 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

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Li Lihuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Reoperation	The incidence of reoperation for excessive bleeding	Participants will be followed for the duration of hospital stay, an expected average of 7 days	No