The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
Recruiting now · Phase 4
Conditions studied: Perioperative Anemia, Surgery, Spinal Deformity, Adult
In brief
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.
Key facts
- Study ID
- NCT05714007
- Run by
- Peking Union Medical College Hospital
- People needed
- 120
- Starts
- 2023-08-31
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Received spinal deformity surgery
- 70 g/L ≤ Hb ≤ 110 g/L at POD1, or Hb at POD1 showed a decrease of
- ≥20 g/L compared with baseline
- Informed consent was obtained voluntarily
You may not qualify if…
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- known serious hypersensitivity to other parenteral iron products
- Non-iron deficiency anemia (e.g., hemolytic anemia)
- Decompensated liver insufficiency
- Coexisting active infection
- Drug abuse, including but not limited to opioids, amphetamines, methamphetamine, ketamine, etc.
- Other conditions that the investigator considers inappropriate for participation (e.g. deafness, Parkinson's disease, communication disorders, etc.)
- Participation in another clinical trial within three months prior to this study.
Where it is running
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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