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

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Valve Replacement; Cardiac Surgery-CABG
• Intervention / Treatment: Drug: Epogen; Drug: Normal Saline

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Keith A. Horvath, MD, Johns Hopkins Community Physicians

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 15, 2016
• Study Completion (Actual): February 27, 2017

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: IRB00050961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No