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

NCT05714007 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

  • Perioperative Anemia
  • Surgery
  • Spinal Deformity
  • Adult

Interventions

DRUG

Ferric derisomaltose

Single intravenous dose ferric derisomaltose

DRUG

Ferrous succinate

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

Sponsors & Collaborators

  • Pharmacosmos A/S

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Weiyun Chen, MD · Peking Union Medical College Hospital

  • Jianxiong Shen, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714007 on ClinicalTrials.gov