Preoperative IV iron for teens having spinal fusion to correct scoliosis
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis
This trial will try giving a single IV iron infusion before spinal fusion to see if it helps 10–19-year-olds with scoliosis and low iron by reducing blood transfusions and improving recovery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07217873 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adolescents aged 10–19 with scoliosis or kyphosis scheduled for spinal fusion within six weeks who have iron deficiency (serum ferritin ≤50 μg/L) are the ideal candidates.
Not a fit: Patients without iron deficiency or those with active inflammation (CRP >10 mg/L), iron overload, prior IV iron exposure, pregnancy, or a history of severe iron hypersensitivity are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, preoperative IV iron could reduce the need for blood transfusions and help teens recover physical and cognitive function more quickly after spinal fusion.
How similar studies have performed: IV iron has reduced transfusion needs and improved symptoms in other surgical and adolescent iron-deficiency settings, and a Columbia pilot provided preliminary supportive data, but large randomized data in this exact population are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.