Recruiting NCT07236788
Study on Supplement of Intravenous Ferric Derisomaltose to Prevent Anemia and Improve the Quality of Life in Obese Patients With Iron Deficiency.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iron Isomaltoside injection, Physiological saline solution (as placebo).
- Who it may be relevant to
- Registry conditions: Obesity, Anemia, Iron Deficiencies, Bariatric Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aimed to explore the effects of preoperative intravenous isomaltose iron supplementation versus placebo on postoperative Hb improvement, prevention of postoperative anemia, and improvement in quality of life in patients undergoing bariatric surgery.
Interventions
- Drug Iron Isomaltoside injection
Patients in the isomaltan iron group received intravenous isomaltan iron dissolved in 250 ml of normal saline 3 days prior to surgery. The patients' iron requirements were calculated using a simplified scale, with a maximum single dose of 20 mg/kg. If the dose was insufficient in a single administration, a second infusion was required every other week. The placebo group received an equal volume of 0.9% normal saline. Simplified scale: Hemoglobin (g/L) patient weight \<50kg 50-70kg \>70kg ≥100 - Drug Physiological saline solution (as placebo)
At the same time point, the same dose of physiological saline was infused as the experimental group.
Primary outcome measures
- changes in Hb concentration compared to baseline [Time frame: 3 months post-surgery,]
Secondary outcome measures (3)
- Incidence of anemia [Time frame: 3 months, 6 months and 12 months after surgery]
- Iron metabolism indicators (serum ferritin, serum iron, total iron binding capacity, transferrin saturation) [Time frame: 3 months, 6 months, and 12 months post-surgery]
- The proportion of patients requiring re-treatment for iron deficiency anemia within 12 months post-surgery (Hb < 11 g/dL, SF < 30 μg/L, or SF < 100 μg/L and TSAT < 20%). [Time frame: 12 months post-surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT07236788 · 2024-HX-133