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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• China-Japan Friendship Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Nianrong Zhang Zhang
• Email: znrsd@163.com
• Phone: +86 188 1048 8650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.