Intravenous Iron Treatment for Adolescents with Iron Deficiency Undergoing Spinal Fusion for Scoliosis or Kyphosis

What this Trial Is About

Adolescents and young adults undergoing spinal fusion surgery for scoliosis or kyphosis often face risks of iron deficiency and anemia around the time of surgery. This research aims to study whether giving intravenous iron before surgery can reduce the need for red blood cell transfusions and improve recovery outcomes such as cognitive and physical function. The study focuses on this vulnerable group, mainly adolescent females, who are prone to iron deficiency due to menstrual blood loss and surgical blood loss, making iron management important for better care during surgery. Participants will be randomly assigned to receive either a single dose of intravenous ferric carboxymaltose 15 mgkg up to 750 mg or a placebo of normal saline on the morning of their surgery. Those who do not qualify for randomization may still take part in an observational follow-up to assess outcomes after surgery. The trial uses a quadruple-blind design to compare the effects of preoperative iron supplementation versus placebo in preventing transfusions and improving recovery. Throughout the study, researchers will monitor the incidence and volume of blood transfusions within 4 to 30 days after surgery. They will also evaluate changes in neurocognitive function and patient-reported physical capacity 2 to 3 months following surgery. Participants will undergo assessments before and after surgery to measure these outcomes, helping to determine if improving iron status before surgery benefits recovery. The total participation period covers the preoperative treatment and postoperative follow-up for several months.

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study