Anemia, Iron Deficiency Anemia
Conditions
Keywords
Anemia, Iron, Transfusion
Brief summary
50 patients with anemia scheduled for heart surgery or procedures will be randomized to receive either oral sucrosomial iron or standard-of-care intravenous iron before surgery to see if the oral iron is as effective as intravenous iron in increasing the red blood cell count.
Detailed description
Participants will be randomly assigned in a 1 to 1 ratio to one of two treatment groups. One group will receive intravenous (IV) iron, and the other group will receive oral sucrosomial iron. Participants assigned to the IV iron group will receive two infusions at the University of Rochester Medical Center Center for Perioperative Medicine. Intravenous iron will be administered through a small plastic tube placed into a vein. Saline may be used to maintain the IV line as needed. Participants assigned to the oral sucrosomial iron group will receive capsules to take at home until the date of surgery, with a dosage of two capsules per day. All other aspects of perioperative care will follow standard practice. A blood sample for complete blood count and iron studies will be obtained on the day of surgery. This is typically collected when the IV is placed, so an additional needle stick is usually not required. Randomization applies only to the two treatment arms (intravenous iron and oral sucrosomial iron). The third arm is a non randomized observational cohort for data collection only.
Interventions
DRUGTreatment with oral sucrosomial iron
blood draw on the day of surgery to check hemoglobin and red blood cell count and iron studies
DRUGTreatment with intravenous iron
2 infusions of intravenous iron (ferumoxytol)
Sponsors
Pharmanutra S.p.a.
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Observer blinded
Intervention model description
Randomized 1:1 to IV or oral iron. Hemoglobin and iron study outcomes are planned for the two randomized arms. Participants in the non randomized observational arm will contribute these values only if obtained as part of routine clinical care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Scheduled for elective cardiac surgical procedures, including: * Coronary artery bypass graft surgery (CABG) * Valve procedures * Aortic root procedures * Transcatheter aortic valve implantation (TAVI) * Hemoglobin \<12 g/dL and ≥10 g/dL on a complete blood count obtained at the Center for Perioperative Medicine pre operative visit * Evidence of iron deficiency * Able to provide informed consent * Able to understand spoken and written English
Exclusion criteria
* Scheduled for cardiac surgery requiring deep hypothermia or circulatory arrest * Undergoing heart transplantation or ventricular assist device placement * Lacking capacity to provide informed consent or unable to understand spoken and written English * Baseline hemoglobin \>12 g/dL or \<10 g/dL * Use of anticoagulant medications within 5 days of the Center for Perioperative Medicine visit, or planned initiation of anticoagulant therapy before surgery * History of hemoglobinopathy * History of hematologic malignancy * Bone marrow suppression from non nutritional causes * Vitamin B12 or folate deficiency * Known liver disease * Known kidney disease * Normal serum iron studies at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin from baseline to day of surgery or procedure | From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks | Change in hemoglobin in grams per deciliter from the baseline pre operative complete blood count to the complete blood count obtained on the day of surgery or procedure. Change will be calculated as hemoglobin on the day of surgery minus baseline hemoglobin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment compliance | From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks | Proportion of participants who complete the assigned iron treatment. Compliance is defined as receiving both infusions in the intravenous arm and taking the prescribed capsules in the oral arm, based on pill counts and participant reporting. |
| Proportion of participants receiving any blood transfusion | From the end of surgery or procedure through thirty days post procedure | Number of participants who receive at least one transfusion of blood products after surgery or procedure |
| Change in iron study values from baseline to the day of surgery or procedure | From the pre operative visit to the day of surgery or procedure, up to approximately eight weeks | Change in serum iron, ferritin, and transferrin saturation between baseline and day of surgery |
| Length of intensive care unit stay | 30 days after hospital discharge | Duration of ICU stay in days, from ICU admission after surgery or procedure until ICU discharge. |
| Length of hospital stay | 30 days after hospital discharge | Duration of hospitalization in days, from admission for surgery or procedure until discharge |
| Post operative complications | From the end of surgery or procedure through thirty days | Number of participants who experience any of the following within thirty days: acute kidney injury, stroke, infection requiring antimicrobial therapy, or death. |
Countries
United States
Contacts
Primary ContactMichael Eaton, MD
Backup ContactMarjorie Gloff, MD
Outcome results
None listed