Preoperative Monoferric for Abdominal Surgery

NCT05258825 | Unknown Phase 4 FDA Drug

• 1 other identifier: 2022P000761
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anemia; Surgery

Outcome Measures

Primary Outcomes (1)

• Serum hemoglobin concentration

  change in hemoglobin from baseline after the administration of IV iron

  3-4 weeks after infusion

Secondary Outcomes (1)

• Requirement for perioperative blood transfusion

  1-30 days after surgery

Study Arms (1)

Intravenous Iron Infusion Arm

EXPERIMENTAL

If the patient is found to have iron deficiency anemia, the patient will receive IV iron preoperatively. Patients that agree to be enrolled in the study will be scheduled for the IV iron dose approximately 3-4 weeks prior to surgery. A single IV dose of 1000 mg of Monoferric will be administered. This will be administered at the Brigham and Women's Hospital infusion center and coordinated with the Hematology team.

Drug: Monoferric

Interventions

Monoferric DRUG

A single intravenous dose of 1000 mg of Monoferric will be administered to a patient 3-4 weeks before anticipated surgery.

Intravenous Iron Infusion Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Pharmacosmos A/S: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Jahn MR, Andreasen HB, Futterer S, Nawroth T, Schunemann V, Kolb U, Hofmeister W, Munoz M, Bock K, Meldal M, Langguth P. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011 Aug;78(3):480-91. doi: 10.1016/j.ejpb.2011.03.016. Epub 2011 Mar 23.

  PMID: 21439379 RESULT

• Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019 Sep;94(9):1007-1014. doi: 10.1002/ajh.25564. Epub 2019 Jul 13.

  PMID: 31243803 RESULT

• Wikstrom B, Bhandari S, Barany P, Kalra PA, Ladefoged S, Wilske J, Thomsen LL. Iron isomaltoside 1000: a new intravenous iron for treating iron deficiency in chronic kidney disease. J Nephrol. 2011 Sep-Oct;24(5):589-96. doi: 10.5301/JN.2011.6248.

  PMID: 21240875 RESULT

Related Links

• Company website that manufactures the study drug

MeSH Terms

Conditions

Anemia

Interventions

ferric derisomaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Richard D. Urman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard D. Urman, MD

CONTACT

6177328222; rurman@bwh.harvard.edu

David L. Hepner, MD

CONTACT

6177328222; dhepner@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label study without masking of participant, care provider, investigator or outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Weiner Center for Preoperative Evaluation

Model Details: This is a single arm study with all study patients receiving intravenous iron infusion.

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 28, 2022
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)