Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this project is to determine whether the use of tranexamic acid, a clot-promoting drug, applied topically over the heart in coronary artery bypass graft surgery (CABG) will reduce post operative blood loss. The investigators' hypothesis is that the use of a tranexamic acid-containing cardiac bath prior to chest closure will result in a statistically significant reduction in blood loss and transfusion requirements in patients who undergo CABG.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Saskatoon Health Region
• Treatments: Tranexamic Acid

Criteria

Inclusion Criterion:

• Patients scheduled for elective or urgent CABG of two to six vessels

Exclusion Criteria:

Preoperative:

• Hemoglobin of less than 110g/L

• Under 18 years of age

• Body mass less than 75kg

• Presence of an intra-aortic balloon pump

• Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team

• Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure)

• Ejection fraction (EF) of less than 50%, as determined by echocardiogram or angiography

• Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg (as estimated by right ventricular systolic pressure (RVSP))

• Presence of infectious endocarditis

• Hepatic failure with impaired liver function, including International Normalized Ratio (INR) greater than 1.5

• Known diagnosed bleeding disorder

• History of heparin induced thrombocytopenia and thrombosis (HITT)

• Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10ml/hour

• Allergy to tranexamic acid

• Pregnancy

Intraoperative:

• Discovery of infectious endocarditis

• Need for cardiac surgical intervention in addition to planned coronary CABG

• Development of allergic reaction to tranexamic acid following intravenous infusion