Preoperative IV ferric derisomaltose to prevent anemia and improve quality of life in obese patients having bariatric surgery

Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.

This trial tests whether a single preoperative IV ferric derisomaltose dose, compared with saline placebo, prevents postoperative anemia and improves quality of life for iron-deficient obese patients undergoing bariatric surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07236788 on ClinicalTrials.gov

What this trial studies

Eligible participants receive either an intravenous ferric derisomaltose infusion or a saline placebo before bariatric surgery, and outcomes include postoperative hemoglobin change, incidence of postoperative anemia, and patient-reported quality of life. Adults must have BMI >30 kg/m2, iron deficiency (serum ferritin <100 μg/L and TSAT <20%), and baseline hemoglobin within the specified ranges (men 10–14 g/dL, women 10–13 g/dL). Key exclusions include recent IV iron (within 3 months), iron overload or other hematologic disorders, active infections, significant liver or renal impairment, pregnancy or lactation, and known severe hypersensitivity to parenteral iron. The intervention and follow-up are conducted at China-Japan Friendship Hospital in Beijing.

Who should consider this trial

Good fit: Ideal candidates are adults with BMI >30 kg/m2 who are iron-deficient (ferritin <100 μg/L and TSAT <20%) with mild anemia within the trial Hb ranges and who are scheduled for bariatric surgery.

Not a fit: Patients with normal iron status or iron overload, recent IV iron, significant liver or kidney disease, active infections, pregnancy, or known severe hypersensitivity to parenteral iron are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce postoperative anemia and support faster recovery with better quality of life after bariatric surgery.

How similar studies have performed: Intravenous iron given before surgery has reduced postoperative anemia in other surgical populations, and applying ferric derisomaltose to bariatric patients is consistent with that evidence though data specific to bariatric surgery remain limited.

Eligibility criteria

Inclusion Criteria:

* ① Baseline Hb: Men 10-14 g/dL, Women 10-13 g/dL; ② Iron deficiency: Serum ferritin (SF) \<100 μg/L, and transferrin saturation (TSAT) \<20%; ③ BMI \>30 kg/m2.

Exclusion Criteria:

* ① Known severe hypersensitivity reactions to other parenteral iron supplements; ② Mean corpuscular volume (MCV) \> 100 fL; ③ Received intravenous iron infusion within the past 3 months; ④ Concurrent tumors; ⑤ Concurrent iron overload or other hematologic disorders; ⑥ Concurrent infectious diseases such as hepatitis B; ⑦ Moderately impaired liver function: decompensated cirrhosis or hepatitis, ALT, AST \> 3 × upper limit of normal (ULN); ⑧ Concurrent acute or chronic infections, heart failure, or other diseases affecting iron metabolism; ⑨ Patients with stage 3 or higher chronic renal insufficiency: glomerular filtration rate (eGFR) \< 60 ml/min; ⑩ Pregnant or lactating women; ⑪ Acute infections, rheumatoid arthritis, or significant joint inflammation.

Where this trial is running

Beijing

• China-Japan Friendship Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Nianrong Zhang Zhang

Conditions Obesity; Anemia; Iron Deficiencies; Bariatric Surgery