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Completed Phase 4 Interventional

Preoperative Monoferric for Abdominal Surgery

ClinicalTrials.gov ID: NCT05258825

Public ClinicalTrials.gov record NCT05258825. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 7:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Use of Preoperative Monoferric Infusion for Enhanced Recovery After Surgery-driven Elective Abdominal Surgery

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05258825
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
37 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 17, 2023
Primary completion
Jun 8, 2025
Completion
Jun 24, 2025
Last update posted
Aug 25, 2026

2023 – 2025

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Brigham and Women's Hospital Boston Massachusetts 02115

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05258825, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2026 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05258825 live on ClinicalTrials.gov.

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