IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

NCT07217873 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AAAV9024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Correction; Iron Deficiency; Transfusion Blood; Surgery Complications; Spinal Fusion; Scoliosis Idiopathic Adolescent; Scoliosis Neuromuscular

Keywords

scoliosis; iron deficiency; blood transfusion; spinal fusion; iron supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  4-30 days

Secondary Outcomes (3)

• Percentage of Patients that experienced postoperative change in neurocognitive function

  2 to 3 months

• Percentage of patients that experienced postoperative change in self-reported physical capacity

  2 to 3 months

• Volume of perioperative RBC transfusion

  4 to 30 days

Study Arms (3)

Intravenous ferric carboxymaltose

EXPERIMENTAL

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

Drug: Ferric carboxymaltose IV

Intravenous normal saline

PLACEBO COMPARATOR

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

Drug: Normal Saline (Placebo)

Observational follow-up

NO INTERVENTION

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

Ferric carboxymaltose IV DRUG

Ferric carboxymaltose is an intravenous treatment for iron deficiency.

Intravenous ferric carboxymaltose

Normal Saline (Placebo) DRUG

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

Intravenous normal saline

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Association for the Advancement of Blood & Biotherapies: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Related Publications (1)

• Qiu A, Fliginger D, Feit Y, Hassan F, Lenke LG, Li G, Hod EA, Eisler L. Estimating the prevalence of preoperative iron deficiency and its impact on red blood cell transfusion in adolescents undergoing scoliosis surgery: A pilot study. Transfusion. 2025 May;65(5):851-857. doi: 10.1111/trf.18246. Epub 2025 Apr 7.

  PMID: 40191932 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Scoliosis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Lisa D Eisler, M.D.

CONTACT

212-305-2413; ldl2113@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Randomized, double-blind, placebo controlled trial

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (1)