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RECRUITING
NCT07217873
PHASE2/PHASE3

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

Official title: IntraVenous Iron in Kids With Iron Deficiency and Scoliosis

Key Details

Gender

All

Age Range

10 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-11-21

Completion Date

2027-10-31

Last Updated

2025-11-26

Healthy Volunteers

No

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.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States