Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated June 13, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-01-26; most recent amendment 2025-06-10.
Status change: Not Yet Recruiting → Recruiting 2023-09-28
Trial Details
NCT Number NCT05714007
Lead Sponsor Peking Union Medical College Hospital
Collaborators: Pharmacosmos A/S
Conditions Perioperative Anemia, Surgery, Spinal Deformity, Adult
Enrollment 120 participants
Start Date 2023-08-31
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-13