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

NCT ID: NCT02802592

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-02-27

Brief Summary

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

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.

Conditions

Cardiac Surgery-CABG; Cardiac Valve Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Epogen

1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr

Group Type: ACTIVE_COMPARATOR

Epogen

Intervention Type: DRUG

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Normal Saline

250 ml normal saline infused over 1 hr

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Interventions

Epogen

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Intervention Type: DRUG

Normal Saline

1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm

Intervention Type: DRUG

Other Intervention Names

EPOETIN; Procrit; Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith A. Horvath, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Community Physicians

Locations

Suburban Hospital

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

IRB00050961

Identifier Type: -

Identifier Source: org_study_id