Clinical trial NCT02802592: EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Official title: EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cardiac Surgery-CABG
Cardiac Valve Replacement
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period
timeFrame: Start of surgery to 96 hours post op
Secondary outcomes:
measure: Length of Stay (# of Total Days Hospitalized)
timeFrame: up to one year from date of surgery
measure: Overall Hospitalization Cost
timeFrame: up to one year from date of surgery
measure: Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey
timeFrame: assessed at 1-week, 1-month, and 3-months from date of surgery
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Community Physicians
name: Keith A. Horvath, MD
role: PRINCIPAL_INVESTIGATOR
References: