This study is a randomized controlled trial of preoperative oral 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 adolescents undergoing scoliosis surgery.
Research Question(s)/Hypothesis(es):
Primary
* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.
Secondary
* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.
10-26 years old;
diagnosis of scoliosis or kyphosis;
self-reported ability to swallow a tablet;
spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work;
taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;
taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;
Hg <10mg/dL if post-menarchal, Hg < 11 if premenarchal or male
C-reactive protein > 10 mg/L
Parallel
Oral ferrous sulfate
Dietary supplementOral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
Oral placebo tablet
Dietary supplementOral placebo tablet provided as placebo comparator.
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 t surgical hospitalization will be tallied.
Percentage of Patients that experienced postoperative decline 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 composite score. A decline of function is measured by comparing the mean change from baseline in the Cognitive Function Composite Scores in the study groups. Higher raw scores reflect higher function in the tested domains, and age-adjustment is then performed such that Age-Corrected Standard scores compare the score of the test-taker to those in the NIH Toolbox nationally representative normative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age.
Percentage of patients that experienced postoperative decline 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 with a mean of 50 and SD of 10 in 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
National Institute of General Medical Sciences (NIGMS)
Collaborator
