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Preoperative Monoferric for Abdominal Surgery
Sponsor: Brigham and Women's Hospital
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
Official title: The Use of Preoperative Monoferric Infusion for Enhanced Recovery After Surgery-driven Elective Abdominal Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2023-04-18
Completion Date
2025-06-25
Last Updated
2026-08-26
Healthy Volunteers
No
Interventions
Monoferric
A single intravenous dose of 1000 mg of Monoferric will be administered to a patient 3-4 weeks before anticipated surgery.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States