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

Cardiac Valve Replacement Clinical Trial

— EPORT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02802592
• Other study ID #: IRB00050961
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2015
• Est. completion date: February 27, 2017

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 27, 2017
• Est. primary completion date: June 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery-CABG
• Cardiac Valve Replacement

Intervention

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

Locations

Country	Name	City	State
United States	Suburban Hospital	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period		Start of surgery to 96 hours post op
Secondary	Length of Stay (# of Total Days Hospitalized)		up to one year from date of surgery
Secondary	Overall Hospitalization Cost		up to one year from date of surgery
Secondary	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