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RECRUITING
NCT05714007
PHASE4

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: The Effects of Ferric Derisomaltose on Postoperative Anemia in Patients Undergoing Spinal Deformity Surgery: A Prospective Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-08-31

Completion Date

2025-12

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

DRUG

Ferric derisomaltose

Single intravenous dose ferric derisomaltose

DRUG

Ferrous succinate

Daily oral dose of 100 mg iron (ferrous succinate) tid postoperatively

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China