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Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient

RecruitingPhase 3Ages 18 Years - anyAllAuerbach Hematology Oncology Associates P C
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In plain words

What the trial is, and whether it could suit you

Given the limited long-term effectiveness of traditional weight loss methods, bariatric surgery is increasingly becoming the preferred option for sustained weight loss. With the ascendancy of the laparoscopic approach, the two most common procedures are the Roux-en-Y gastric bypass (RYGB) and the vertical sleeve gastrectomy (VSG). Because bariatric surgery decreases nutrient intake through restriction, malabsorption, or both, and given that obese patients are often malnourished even before surgery, postoperative micronutrient deficiency, particularly of iron, can be a serious complication and difficult to treat. Iron deficiency anemia has been reported to be as high as 49% in the post-bariatric surgical patient. The current standard for correcting iron deficiency anemia in the post-operative bariatric surgical patient is oral iron supplements. However, oral iron therapy is known for it

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: 1. Aged โ‰ฅ 18 years 2. Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery. 3. Iron deficiency anemia defined as iron deficient with either ferritin\<30 mcg/l, TSAT\<20%, or anemia with Hgb\<13 g/dL for both males and females. 4. Willingness to participate and signing the informed consent form. Exclusion criteria: 1. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis) 2. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal) 3. Serum ferritin \> 400 ng/mL or transferrin saturation \>40 % 4. Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available) 5. Rheumatoid arthritis with symptoms or signs of active inflammation 6. Pregnant and nursing women 7. History of multiple allergies (two or more) 8. Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products 9. Previous IV iron treatment for IDA 10. Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit 11. Planned elective surgery during the study 12. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus
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What it tests

  • Ferumoxytol
  • Saline
  • Ferrous sulfate tablets
  • Vitamin C
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Where

1 site
Auerbach Hematology and Oncology
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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