IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Scoliosis Correction, Iron Deficiency, Transfusion Blood, Surgery Complications, Spinal Fusion, Scoliosis Idiopathic Adolescent, Scoliosis Neuromuscular
In brief
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.
Key facts
- Study ID
- NCT07217873
- Run by
- Columbia University
- People needed
- 120
- Starts
- 2025-11-21
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2025-11-26
Who can join
Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify 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
Where it is running
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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