drugset / Trial / NCT05714007

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

NCT05714007

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

EvaluationDrugModalityDoseRoute
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

Indications