Cardiac Surgery-CABG, Cardiac Valve Replacement
Conditions
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.
Interventions
DRUGEpogen
1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
DRUGNormal Saline
1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Participant flow
Pre-assignment details
This study was terminated due to loss of funding and those participants enrolled were not un-blinded to the study team members.
Participants by arm
| Arm | Count |
|---|---|
| All Participants 1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
OR
250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated due to loss of funding | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period
Time frame: Start of surgery to 96 hours post op
Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.
Secondary
Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey
Time frame: assessed at 1-week, 1-month, and 3-months from date of surgery
Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.
Secondary
Length of Stay (# of Total Days Hospitalized)
Time frame: up to one year from date of surgery
Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.
Secondary
Overall Hospitalization Cost
Time frame: up to one year from date of surgery
Population: This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.