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IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

RecruitingPhase 2, Phase 3Ages 10 Years - 19 YearsAllColumbia University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮผg/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
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What it tests

  • Ferric carboxymaltose IV
  • Normal Saline (Placebo)
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Where

1 site
Columbia University Irving Medical Center
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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