Status:
COMPLETED
Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Saskatoon Health Region
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ope...
Detailed Description
Bleeding is expected during major surgeries. In patients who undergo CABG, the risk for bleeding is increased because of the need for intra-operative anticoagulation, or thinning, of patient blood. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01519245
Start Date
December 1 2011
End Date
June 1 2012
Last Update
July 2 2013
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