IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07217873
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Ferric carboxymaltose IV — DRUG
    Ferric carboxymaltose is an intravenous treatment for iron deficiency.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 21, 2025
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion [ Time Frame: 4-30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-

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Columbia University Irving Medical Center· New York, NY

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