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IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Sponsor: Columbia University
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
Conditions
Interventions
Ferric carboxymaltose IV
Ferric carboxymaltose is an intravenous treatment for iron deficiency.
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