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

Study Overview
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Brief Summary
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EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)

Detailed Description
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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.

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

Conditions
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Cardiac Surgery-CABG, Cardiac Valve Replacement

Intervention / Treatment
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* Drug: Epogen
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epogen<br>1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr | Drug: Epogen<br>* 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm<br>* Other names: Procrit;|
| Placebo Comparator: Normal Saline<br>250 ml normal saline infused over 1 hr | Drug: Normal Saline<br>* 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |