Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Postoperative Hemorrhage
Intervention: Tranexamic Acid; normal saline
Intervention description: Solution containing 2 grams (20mL) tranexamic acid + normal saline (50mL), for a total volume of 70mL poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction.; A total volume of 70mL of normal saline poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction. Identical in appearance to the trial drug, and is visually indistinguishable.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: coronary artery bypass grafting; tranexamic acid; antifibrinolytic; administration, topical; operative blood salvage

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.
    

Eligibility 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