IntraVenous Iron in Kids With Iron Deficiency and Scoliosis
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.
Description
Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and perioperative red blood cell transfusion, which are associated with adverse outcomes in this population. These patients are mostly adolescent females, a group more susceptible to iron deficiency and resulting anemia at baseline due to iron losses with menses, and who suffer an additional insult to iron stores during surgery. Nevertheless, iron status is not routinely monitored in this setting and…
Eligibility
- Age range
- 10–19 years
- Sex
- All
- Healthy volunteers
- No
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 h…
Interventions
- DrugFerric carboxymaltose IV
Ferric carboxymaltose is an intravenous treatment for iron deficiency.
- DrugNormal Saline (Placebo)
Normal saline is the recommended diluent for ferric carboxymaltose, and on its own serves as the placebo control for this study.
Location
- Columbia University Irving Medical CenterNew York, New York