EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

• Status: Terminated
• Trial end date: 2017-02-27
• Target enrollment: 0
• Participant gender: All

Summary

EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Be male or female and 18 years of age or older, but less than 65 years of age

• Be willing to performed written informed consent prior to study initiation

• Be willing and able to comply with the protocol for study duration

• Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.

Exclusion Criteria:

• Over the age of 64 years

• Patients who receive allogeneic transfusion 60 days prior to surgery

• Hgb > 15g/dl

• Patients who are pregnant or currently lactating

• Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.

• End-stage renal disease requiring renal replacement therapy or dialysis

• Hepatic dysfunction (defined as total bilirubin value > 1.5 mg/dl)

• Off-pump (no CPB) cardiac surgery

• Emergency surgical procedure

• Inability to receive blood products

• Endocarditis as defined my Modified Duke Criteria

• Any congenital coagulation disorder

• Chronic anemia (defined as preoperative Hgb concentration < 10 g/dl)

• Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)

• Not a surgical candidate due to high risk of morbidity or mortality

• Surgery for aneurysm repair, dissection, or other thoracic aortic procedure

• Congenital heart surgery

• Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery, as defined by systolic blood pressure < 80 mmHg and heart rate > 120 beats per minute

• Known malignancy within the past 5 years

• Life expectancy < 12 months

• Current active infection requiring antibiotic treatment

• Inability to comply with study protocol

• Contraindication to Epogen

• Hypersensitivity to epoetin or any component of the formulation

• Pure red cell aplasia (due to epoetin or other epoetin protein drugs)

• Contraindication to Ferrous Sulfate

• Hypersensitivity to iron salts or any component of the formulation

• Hemochromatosis

• Hemolytic anemia

• In the opinion of the Principle Investigator (PI) any specific disease process or confounding variables that may inappropriately alter the outcome of the study