drugset / Trial / NCT05714007
The Effects of Ferric Derisomaltose on Postoperative Anemia in Spinal Deformity Surgery
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2023-08-31
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric Derisomaltose | Unknown | 500 mg | Intravenous |
| Subject | Ferric Derisomaltose | Unknown | 1000 mg | Intravenous |
| Subject | Ferric Derisomaltose | Unknown | 1500 mg | Intravenous |
| Subject | Ferric Derisomaltose | Unknown | 2000 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 100 mg | Oral |