Effects of Ferric Derisomaltose on Anemia After Spinal 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

This clinical trial evaluates the effectiveness of intravenous ferric derisomaltose in treating postoperative anemia in adults undergoing spinal deformity surgery. Participants will be randomly assigned to receive either ferric derisomaltose or oral iron, with the study measuring changes in hemoglobin levels, anemia correction rates, and patient quality of life. The trial aims to determine if intravenous iron can provide a faster and more effective solution compared to traditional oral iron, especially in the context of postoperative inflammation that affects iron absorption.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Weiyun Chen, MD — Peking Union Medical College Hospital
• Study coordinator: Jianxiong Shen, MD
• Email: sjxpumch@163.com
• Phone: 01069152701

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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.