Efficacy of Tranexamic Acid and Epsilon-aminocaproic Acid in Reducing Bleeding and Transfusions in Cardiac Surgery

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Aminocaproic Acid; Anesthetics; Polystyrene sulfonic acid; Tranexamic Acid

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