Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery
Status:
Terminated
Trial end date:
2019-07-26
Target enrollment:
Participant gender:
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.