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 ↗
Who can join
Age 10 Years – 19 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 10 -19 years old
- Diagnosis of scoliosis or kyphosis
- Scheduled for imminent spinal fusion procedure (<6 weeks) at MS-CHONY
- Iron deficiency or hypoferritinemia, defined as serum ferritin less than or equal to 50 μg/L
You can't join if
- C-reactive protein > 10 mg/L
- Receiving nutritional support by report in the medical chart
- Self-reported history of hypersensitivity reaction to iron-containing supplements
- Self-reported history of receiving intravenous iron supplements
- Self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis
- Objection to receiving red blood cell transfusions
- Current pregnancy (identified by self-report or documentation of preoperative screening test in the medical record)
- Prisoners
- Patient or parent decides against study participation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openColumbia University Irving Medical Center
New York, New York, United States
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAV9024
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.