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COMPLETED
NCT05258825
PHASE4

Preoperative Monoferric for Abdominal Surgery

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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

Conditions

Interventions

DRUG

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