Effects of Ferric Derisomaltose on Anemia After Spinal Surgery
The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study
This study is testing if an intravenous iron treatment can help adults recovering from spinal surgery feel better and fix their anemia faster than taking oral iron.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05714007 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone spinal deformity surgery and meet specific hemoglobin criteria.
Not a fit: Patients with non-iron deficiency anemia, serious hypersensitivity to iron products, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for patients undergoing spinal deformity surgery by effectively addressing postoperative anemia.
How similar studies have performed: Other studies have shown promising results with intravenous iron therapies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.