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.
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
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
Parallel
Ferric carboxymaltose IV
DrugFerric carboxymaltose is an intravenous treatment for iron deficiency.
Normal Saline (Placebo)
DrugNormal saline is the recommended diluent for ferric carboxymaltose, and on its own serves as the placebo control for this study.
Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion
The patients that received a red blood cell transfusion either during procedure or postoperatively during their surgical hospitalization will be tallied.
Percentage of Patients that experienced postoperative change in neurocognitive function
The Cognitive Battery of the NIH Toolbox is a brief, valid, and reliable instrument designed to provide outcome measures in epidemiologic and longitudinal research that can be used for comparisons across a wide range of studies and populations. Individual measure scores in the battery reflect Executive Function, Attention, Verbal and Nonverbal Memory, Language, Processing Speed, and Working Memory, yielding a composite score. This composite is scored on a T-score, with 100 representing the mean normalized by age and education level, and a standard deviation of 10. A score of 100 indicates performance that was at the national average for the test-taking participant's age. Scores of 85 or lower indicate below average cognitive function. A decline of function is measured by comparing the mean change from baseline in the Cognitive Function Composite Scores in the study groups.
Percentage of patients that experienced postoperative change in self-reported physical capacity
The PROMIS pediatric measures are a NIH Roadmap initiative to provide access to valid and reliable self-reported measures of health-related quality of life in children and adolescents. The PROMIS measures are scored on a T-score metric, where a score of 50 and standard deviation of 10 represents the average score for the general population in the United States. Higher PROMIS symptom scores indicate increased symptom burden, and higher PROMIS function scores indicate increased functioning. Decline would be identified through a mean change (decrease) from baseline in the Physical Functioning - Mobility scores; with secondary hypotheses for Physical Functioning - Upper Extremity, Physical Activity, and Fatigue.
Volume of perioperative RBC transfusion
The volume that each patient receives either during procedure or postoperatively during surgical hospitalization will be summed and average calculated.
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Columbia University
Lead sponsor
Association for the Advancement of Blood & Biotherapies
Collaborator
