Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery
Condition: Bleeding
MeSH terms: Hemorrhage
Intervention: Epsilon-aminocaproic acid administered; Tranexamic Acid administered
Intervention description: Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.; Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators primary objective is to compare the effectiveness of epsilon-aminocaproic
      acid (EACA) and tranexamic acid (TA) in reducing bleeding and transfusion in cardiac surgery,
      with the hypothesis that TA is more effective. The investigators also seek to further examine
      the clinical benefits and adverse effects profiles of epsilon-aminocaproic acid and
      tranexamic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities

          -  Subjects scheduled to undergo cardiac surgery requiring cardiopulmonary bypass

        Exclusion Criteria:

          -  Vulnerable patient populations (unable to consent)

          -  Religious or other prohibitive reason for not receiving blood transfusion

          -  History of allergy to epsilon-aminocaproic acid or tranexamic acid

          -  Pregnant or breast-feeding (if applicable)

          -  The participation in another clinical or device trial that would affect the patient's
             coagulation profile

          -  Cardiac or cardiopulmonary transplantation procedure

          -  Any history of stroke and/or non-coronary thrombotic disorders (DVT, PE)

          -  Clinical signs consistent with non-coronary thrombotic disease

          -  Known congenital deficiency of Protein C, Protein S, Antithrombin and homozygous
             Factor V Leiden

          -  Known congenital bleeding disorders

          -  Weight < 50 kg

          -  Weight > 150 kg

          -  Acute renal failure or creatinine > 2.0 mg/dL

          -  Current surgery including any implantable ventricular assist device requiring CPB
             including ECMO (extracorpeal membrane oxygenation)

          -  Current surgery including the aortic arch and/or descending thoracic aorta

          -  Any changes to the planned surgery, which result int he patient not requiring CPB or
             meeting exclusion criteria