IntraVenous Iron in Kids With Iron Deficiency and Scoliosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Lisa D Eisler, M.D.
ldl2113@cumc.columbia.edu
212-305-2413
Time Frame
Start Date: 2025-11-21
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Association for the Advancement of Blood & Biotherapies

This content was sourced from clinicaltrials.gov