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Scoliosis CorrectionCognitive functionChildren's healthDrugPhase 2, Phase 3

What this study is

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.

What's being tested

  • Ferric carboxymaltose IV

    Intervention · DRUG

    Ferric carboxymaltose is an intravenous treatment for iron deficiency.

  • Normal Saline (Placebo)

    Intervention · DRUG

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

Study details

Official title
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis
Sponsor
Columbia University
Conditions
Scoliosis Correction · Iron Deficiency · Transfusion Blood · Surgery Complications · Spinal Fusion · Scoliosis Idiopathic Adolescent · Scoliosis Neuromuscular
Enrolling
120 people
Starts
2025-11-21
Est. completion
2027-10-31
Design
Quadruple-blind, randomized, parallel groups, Phase 2, Phase 3
Record
View on ClinicalTrials.gov ↗