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Recruiting Phase 2, Phase 3 NCT07217873

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

◆ AI Clinical Summary

This study looks at whether giving iron through an IV (intravenous) before spinal fusion surgery can help prevent anemia and reduce the need for blood transfusions in teenagers and young adults having scoliosis correction surgery. Iron deficiency anemia is common in patients undergoing this type of surgery, which can complicate recovery.

Key Objective: The trial is testing whether IV iron treatment before surgery can improve iron levels and reduce anemia-related complications in adolescents and young adults undergoing spinal fusion for scoliosis.

Who to Consider: Teenagers and young adults who are scheduled to have spinal fusion surgery for scoliosis or other spinal deformities and who have or are at risk for iron deficiency should consider enrolling.

Trial Parameters

Condition Scoliosis Correction
Sponsor Columbia University
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 120
Sex ALL
Min Age 10 Years
Max Age 19 Years
Start Date 2025-11-21
Completion 2027-08-31
Interventions
Ferric carboxymaltose IVNormal Saline (Placebo)

Brief Summary

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

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

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