Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery

• Status: Terminated
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

Summary

Anemia which is a decreased blood count or lower than normal hemoglobin (hgb), is a major health problem for patients having heart surgery. Hemoglobin is the part of our blood that carries oxygen from the lungs to the rest of the body. Anemia that is present before surgery, called preoperative anemia, is a risk factor for an increased chance of morbidity (illness) and/or mortality (death) after heart surgery. It is also an important indicator of blood transfusion necessity. Recent clinical research investigations done to study preoperative anemia suggest a blood transfusion can damage the immune system (the system that protects us from disease) which can lead to infection, organ dysfunction (especially of the heart, kidney, brain), prolonged hospital stays, as well as increased supplies, resources and cost in surgical patients. Comprehensive anemia management can reduce or eliminate the need for blood transfusions and provide better outcomes after surgery. Therefore, controlling anemia before surgery is extremely important, and could be a lifesaving measure.

This pilot, feasibility study is being done for several reasons. First of all, it will test the the safety and effectiveness of using a short-course of two medications, erythropoietin (EPO) and Feraheme (iron given intravenously [IV]), to increase hemoglobin levels in order to improve preoperative anemia, reduce transfusions and lower postoperative complications in anemic patients undergoing heart surgery. Secondly, findings will be used to design a large randomized controlled trial (RCT). The RCT will establish a protocol to actively manage anemia before surgery, thus reducing transfusions during surgery and improving recovery afterwards. It will also help identify valuable information regarding what needs to be done for timely completion of the planned RCT.

EPO is a medication approved by the Food and Drug Administration (FDA) used to treat anemia in patients with certain conditions in order to reduce blood transfusions. And although approved for use during surgery, it has not been FDA approved for use in cardiac (heart) or vascular (blood vessels, including veins and arteries) surgery. Common side effects include nausea, vomiting, itching, headache, injection site pain, chills, deep vein thrombosis (blood clot), cough, and changes in blood pressure (BP). Feraheme is an iron replacement product approved for the treatment of low iron anemia in adult patients. It may cause serious allergic reactions, including anaphylaxis (severe, whole body allergic reaction), as well as low BP and excessive iron storage.

Patients meeting all eligibility requirements that consent to participate will be randomized into the study. Randomization is being placed by chance (like a flip of a coin) into one of two study groups, the treatment group or the control group. There is an equal chance of being placed into either group, which will be done by a computer.

1. The Treatment Group will receive a 300 unit (U) per kilogram (kg) injection of EPO and a 510 milligram (mg) IV infusion of Feraheme 7-28 days before the day of surgery. And again 1-7 days before the day of surgery, a second dose of both of these medications will be given. The third dose, of EPO only, will be administered 2 days after surgery. Before initiating a dose or giving a subsequent dose, laboratory parameters will be measured to assess the hemoglobin level and response to the medication. If blood values increase too rapidly or are too high, the meds will not be started or, if already dosed, they will not be given again.

2. The Control Group will receive no preoperative intervention for anemia unless lab results show iron deficiency anemia. The control group will be screened for the presence of iron deficiency anemia by evaluating blood laboratory values drawn during the baseline or preoperative visit. If lab results indicate iron deficiency anemia, over-the-counter oral iron will be recommended, to take until the day of surgery. In doing so, patients may benefit by potentially reducing the need for blood transfusions.

Data will be collected from all participants from the preoperative visits throughout the admission, including lab results, medications, vital signs, information about the procedure, transfusions, and any problems or adverse events.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Epoetin Alfa; Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• between the age of 18 and 80 years old

• diagnosed with preoperative anemia, defined as hemoglobin <13.0 grams per deciliter (g/dL)

• scheduled for elective cardiac surgery (CABG, valve, or CABG/valve), including both first time and repeat procedures

• documented negative pregnancy test within 7 days prior to the procedure for females of child-bearing potential

• a written informed consent prior to any procedure, using a form that is approved by the UT Southwestern Institutional Review Board

• agreement to be compliant

Exclusion Criteria:

• uncontrolled hypertension (defined as systolic pressure greater than 180 millimeters of mercury (mmHg), diastolic pressure greater than 100mmHg, not adequately controlled by anti-hypertensive therapy at the time of procedure)

• current renal failure on dialysis or serum creatinine >3.0 milligrams per deciliter (mg/dL)

• unstable angina (defined by chest pain and EKG changes indicating ischemia at rest)

• thromboembolism within the past year

• current active primary or metastatic malignancy or history of myeloid malignancy

• seizures within the past year

• history of stroke within the last 6 months

• patients who have platelet count lower than 50,000 per cubic millimeter (mm3) or coagulation abnormality

• sepsis or bacteremia defined by positive blood culture

• patients who have known hypersensitivity to EPO or any of its components

• patients who have known hypersensitivity to Feraheme or any of its components

• patients who refuse blood transfusion, (i.e. Jehovah's Witnesses)

• pregnant or breast feeding

• patients who are unable to provide informed consent or who has inability to understand or corporate with study procedure