Actively Recruiting
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Led by Columbia University · Updated on 2025-11-26
120
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
Association for the Advancement of Blood & Biotherapies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 10 to 19 years old
- Have a diagnosis of scoliosis or kyphosis
- Be scheduled for spinal fusion surgery within 6 weeks at MS-CHONY
- Have iron deficiency or low iron stores (serum ferritin ≤ 50 µg/L)
You will not qualify if you...
- C-reactive protein level greater than 10 mg/L
- Currently receiving nutritional support
- History of allergic reaction to iron-containing supplements
- History of receiving intravenous iron supplements
- History of iron overload conditions like hereditary hemochromatosis or hemosiderosis
- Object to receiving red blood cell transfusions
- Currently pregnant
- Prisoner status
- Patient or parent decides against participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Lisa D Eisler, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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