Preoperative Monoferric for Abdominal Surgery

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Although there are multiple formulations of intravenous (IV) iron to choose from, a one-time dose of Monoferric would make it more feasible to integrate it in the perioperative pathway given an often-limited time between preoperative evaluation and surgery date. Furthermore, the one-dose total iron repletion model can offer health economic benefits through reducing red blood cell (RBC) transfusion applying limited resources to establish a perioperative anemia management pathway. Prior studies have described a model that can be used as a baseline which showed cost-savings and outlined each cost component. So far, no US-based approach applying this model has been published.

Hypothesis: Administration of a one-time dose of IV iron to patients with preoperative iron deficiency anemia scheduled to undergo elective abdominal and/or pelvic surgery is feasible. It will result in an increase in preoperative hemoglobin from baseline, and improvement in clinical outcomes.

Aim 1: Determine the change in hemoglobin from baseline after the administration of 1000mg single dose IV iron 3-4 weeks before elective surgery The investigators hypothesize that there will be an increase in hemoglobin levels by 1g/dL by the day of surgery.

Aim 2: Explore the association of IV iron administration on other clinical outcomes including: complications, transfusion of blood products and length of hospital stay.

The investigators hypothesize that there will be a decrease in adverse complications and requirement for transfusion, and shorter hospital stay

Aim 3: Describe the feasibility and process, infrastructure and workflows required to implement an IV iron infusion program

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Pharmacosmos A/S

Criteria

Inclusion Criteria:

• Men or women ≥18 years old

• Hemoglobin ≤12 g/dL, and ferritin <30ng/mL or transferrin <20%

• Scheduled to undergo elective abdominal/pelvic surgery

• Willingness to participate and sign the informed consent form

Exclusion Criteria:

• Non-iron deficiency anemia

• Hemochromatosis or other iron storage disorders

• Previous serious hypersensitivity reactions to any IV iron compounds

• Treated with intravenous iron within 10 days of IV iron intervention

• Patient has or will be treated with a red blood cell transfusion within 30 days of scheduled surgery

• Received another investigational drug within 30 days of scheduled surgery

• Requiring dialysis or being considered for dialysis

• Already on erythropoietin stimulating agents

• Evidence of decompensated liver cirrhosis or active hepatitis

• Active infection, sepsis

• Alcohol or drug abuse within the past 6 months

• Estimated life expectancy of < 1 year

• Pregnant or nursing women

• Expecting excessive surgical bleeding