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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	250 ml normal saline infused over 1 hr
Epogen	Epogen	1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr

Primary Outcome Measures

Name	Time	Method
Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period	Start of surgery to 96 hours post op

Secondary Outcome Measures

Name	Time	Method
Length of Stay (# of Total Days Hospitalized)	up to one year from date of surgery
Overall Hospitalization Cost	up to one year from date of surgery
Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey	assessed at 1-week, 1-month, and 3-months from date of surgery