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The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery

RecruitingPhase 4Ages 18 Years - anyAllPeking Union Medical College Hospital
NCT05714007 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The prognosis of patients undergoing spinal deformity surgery is often compromised by perioperative anemia due to iron deficiency. The aim of this randomized, controlled trial was to evaluate whether postoperative ferric derisomaltose intravenous injection may improve anemia and prognosis in patients undergoing spinal deformity surgery comparing with oral iron. Participants will be randomly assigned to the treatment group (intravenous ferric derisomaltose) and the control group (oral iron). Changes in hemoglobin concentration, percentage of anemia correction, changes in iron indicators, patient quality of life, and incidence of adverse events will be analyzed to evaluate the efficacy and safety of iron isomaltoside infusion.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Age ≥18 years 2. Received spinal deformity surgery 3. 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of ≥20 g/L compared with baseline 4. Informed consent was obtained voluntarily Exclusion Criteria 1. Women who are pregnant, breastfeeding, or planning to become pregnant. 2. known serious hypersensitivity to other parenteral iron products 3. Non-iron deficiency anemia (e.g., hemolytic anemia) 4. Decompensated liver insufficiency 5. Coexisting active infection 6. Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc. 7. Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.) 8. Participation in another clinical trial within three months prior to this study.
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What it tests

  • Ferric derisomaltose
  • Ferrous succinate
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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