Estimating the prevalence of preoperative iron deficiency and its impact on red blood cell transfusion in adolescents undergoing scoliosis surgery: A pilot study.
Annie Qiu, Daysha Fliginger, Yona Feit...
https://pubmed.ncbi.nlm.nih.gov/40191932Actively Recruiting
Phase 2
Phase 3
Age: 10Years - 19Years
All Genders
ID07217873
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis
Led by Columbia University · Updated on 2025-11-26
120
Participants Needed
1
Research Sites
8 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 scoliosis or kyphosis often face risks of iron deficiency and anemia around the time of surgery. This research aims to study whether giving intravenous iron before surgery can reduce the need for red blood cell transfusions and improve recovery outcomes such as cognitive and physical function. The study focuses on this vulnerable group, mainly adolescent females, who are prone to iron deficiency due to menstrual blood loss and surgical blood loss, making iron management important for better care during surgery. Participants will be randomly assigned to receive either a single dose of intravenous ferric carboxymaltose (15 mg/kg up to 750 mg) or a placebo of normal saline on the morning of their surgery. Those who do not qualify for randomization may still take part in an observational follow-up to assess outcomes after surgery. The trial uses a quadruple-blind design to compare the effects of preoperative iron supplementation versus placebo in preventing transfusions and improving recovery. Throughout the study, researchers will monitor the incidence and volume of blood transfusions within 4 to 30 days after surgery. They will also evaluate changes in neurocognitive function and patient-reported physical capacity 2 to 3 months following surgery. Participants will undergo assessments before and after surgery to measure these outcomes, helping to determine if improving iron status before surgery benefits recovery. The total participation period covers the preoperative treatment and postoperative follow-up for several months.
CONDITIONS
Brief Title
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Who Can Participate
Age: 10Years - 19Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 10 and 19 years
- Diagnosis of scoliosis or kyphosis
- Scheduled for spinal fusion surgery within 6 weeks
- Iron deficiency or low ferritin defined as serum ferritin 50 micrograms per liter
You will not qualify if you...
- C-reactive protein greater than 10 mg/L
- Receiving nutritional support as noted in medical records
- History of allergic reaction to iron supplements
- Previous intravenous iron treatment
- History of iron overload conditions such as hereditary hemochromatosis or hemosiderosis
- Refusal to receive red blood cell transfusions
- Current pregnancy
- Prisoner status
- Patient or parent refuses study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 6 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility including iron status
Treatment
Duration - Day of surgery
Participants receive a one-time intravenous dose of ferric carboxymaltose or placebo on the morning of spinal fusion surgery to address iron deficiency.
1 visit (in-person) on surgery day
Post-operative Follow-up
Duration - 2 to 3 months after surgery
Participants are monitored for recovery including neurocognitive function and physical capacity after surgery.
Follow-up assessments at 2 to 3 months post-surgery
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
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Research Team
L
Lisa D Eisler, M.D.
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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