Status:
UNKNOWN
Preoperative Monoferric for Abdominal Surgery
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Pharmacosmos A/S
Conditions:
Anemia
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-...
Detailed Description
The Food and Drug Administration approved drug Monoferric has a unique structure that allows for a slow, sustained release and bioavailability without free iron toxicity. Efficacy studies demonstrated...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05258825
Start Date
November 1 2022
End Date
April 1 2023
Last Update
October 12 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115