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

Johns Hopkins University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Cardiac Valve Replacement

Cardiac Surgery-CABG

Treatments

Drug: Normal Saline

Drug: Epogen

Study type

Interventional

Funder types

Other

Identifiers

NCT02802592

IRB00050961

Details and patient eligibility

About

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

Full description

The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age < 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.

Enrollment

4 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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