IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-19
SponsorColumbia University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ferric carboxymaltose IV
  • Normal Saline (Placebo)

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Columbia University

Lead sponsor

Association for the Advancement of Blood & Biotherapies

Collaborator