Preoperative IV iron for teens having spinal fusion to correct scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial enrolls adolescents and young adults (ages 10–19) with scoliosis or kyphosis and iron deficiency (serum ferritin ≤50 μg/L) who are scheduled for spinal fusion within six weeks at Columbia University. Participants are assigned to receive a preoperative infusion of ferric carboxymaltose or saline placebo and are followed for perioperative transfusion requirements, postoperative cognitive and physical function, and safety. The rationale is that iron deficiency is a modifiable risk factor for transfusion and can impair muscle and brain function even without frank anemia. The study will test whether correcting iron deficiency before surgery lowers transfusion rates and improves functional recovery in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Lisa D Eisler, M.D.
• Email: ldl2113@cumc.columbia.edu
• Phone: 212-305-2413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.