Clinical Trial Finder

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

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 there is no standard of care for preoperative iron supplementation. Iron is a nutritionally essential trace element important not only for red blood cell production, but also for muscle function and neurotransmitter synthesis and signaling. Therefore, supplementation of poor iron status is an important target for optimizing hemoglobin prior to surgery, reducing transfusion rates and associated complications such as alloimmunization, and improving patient outcomes. On its own and as the primary cause of anemia, iron deficiency was identified as the only risk factor for transfusion which is modifiable preoperatively. In addition, iron supplementation is shown to alleviate impairments of physical and cognitive capacity associated with even mild forms of iron deficiency in adolescent and young adult females. A pilot study conducted at Columbia University Irving Medical Center identified iron deficiency in 36% of scoliosis patients prior to surgery, with preoperative iron status highly correlated with iron status during surgical recovery. Consequently, the investigators plan to examine iron deficiency as a modifiable risk factor for transfusion and impaired postoperative cognitive and physical capacity in this vulnerable population. Previous trials of brief iron interventions in high-risk adult surgical patients, mostly with unknown iron status, do not inform the care of adolescents and were not designed to address postoperative functional outcomes. The investigators will therefore perform a single-center randomized controlled trial in which adolescents with scoliosis and/or kyphosis identified using physiologically-based serum markers of poor iron status will be randomized to a one time preoperative dose of IV ferric carboxymaltose or placebo, to test the hypotheses that preoperative iron supplementation 1) reduces the rate of red blood cell transfusion, 2) improves postoperative neurocognition compared to a preoperative baseline, and 3) improves patient reported physical functioning during recovery. This study aims to improve outcomes in this vulnerable population and provide evidence for patient blood management approaches to reduce transfusions amid recent severe blood shortages.

Arms

Experimental: Intravenous ferric carboxymaltose

Participants will receive ferric carboxymaltose, 15mg/kg up to 750mg intravenously, on the morning of surgery.

Placebo Comparator: Intravenous normal saline

Patients will receive normal saline, intravenously, on the morning of surgery.

No Intervention: Observational follow-up

Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.

Interventions

Drug: - Ferric carboxymaltose IV

Ferric carboxymaltose is an intravenous treatment for iron deficiency.

Drug: - Normal Saline (Placebo)

Normal saline is the recommended diluent for ferric carboxymaltose, and on its own serves as the placebo control for this study.