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IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

NCT07217873 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-11-26

No results posted yet for this study

Summary

Adolescents and young adults undergoing spinal fusion surgery for the correction of scoliosis and other spinal deformity are at high risk of perioperative iron deficiency and anemia, yet the means and evidence for optimizing iron status have not been described in this setting. The proposed study is a randomized controlled trial of preoperative intravenous iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in this vulnerable population. Building evidence for patient blood management interventions such as iron supplementation is vital to ensuring high quality care of surgical patients and may reduce unnecessary transfusions amid recent blood shortages.

Conditions

  • Scoliosis Correction
  • Iron Deficiency
  • Transfusion Blood
  • Surgery Complications
  • Spinal Fusion
  • Scoliosis Idiopathic Adolescent
  • Scoliosis Neuromuscular

Interventions

DRUG

Ferric carboxymaltose IV

Ferric carboxymaltose is an intravenous treatment for iron deficiency.

DRUG

Normal Saline (Placebo)

Normal saline is the recommended diluent for ferric carboxymaltose, and on its own serves as the placebo control for this study.

Sponsors & Collaborators

  • Association for the Advancement of Blood & Biotherapies

    collaborator UNKNOWN

  • Columbia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2027-08-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT07217873 on ClinicalTrials.gov