Sucrosomial Vs Intravenous Iron for Preoperative Anemia (RSIVI)

University of Rochester

Status and phase: Not yet enrolling; Phase 4

Conditions: Iron Deficiency Anemia; Anemia

Treatments: Drug: Treatment with oral sucrosomial iron; Drug: Treatment with intravenous iron

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07287371

STUDY00000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

intravenous (IV) iron

Active Comparator group

Description:

If a participant is to receive IV iron, they will be scheduled to have two infusions, at the URMC Center for Perioperative Medicine (CPM). They will receive the iron through an IV, which is a small plastic tube inserted into a vein in the arm using a needle. This may require that saline water be inserted into the tube to keep the tube from clogging.

Treatment:

Drug: Treatment with intravenous iron

Sucrosomial Iron

Experimental group

Description:

If a participant is to receive oral iron capsules, they will be provided with enough capsules to last until the date of surgery and will take 2 capsules every day.

Treatment:

Drug: Treatment with oral sucrosomial iron

3rd arm is for data collection only

No Intervention group

Description:

In addition, 25 patients refusing randomization, but accepting data collection, will be treated as per the standard of care, but will have data collected as for the randomized groups with the exception of no CBC or iron studies will be performed on the day of surgery unless as part of routine care unrelated to study participation.