IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Recruiting
Phase 2
Phase 3
Interventional Study
Scoliosis Correction
Iron Deficiency
Transfusion Blood
Surgery Complications
Spinal Fusion
Scoliosis Idiopathic Adolescent
Scoliosis Neuromuscular
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 10 – 19
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 120 (estimated)
- Sponsor
- Columbia University · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* C-reactive protein \> 10 mg/L
*…
Contacts