Correction of preoperative iron deficiency in children undergoing elective spinal fusion. A Randomised control trial of Intravenous Iron vs. Oral Iron therapy.

Phase 3

• Conditions: Iron deficiency; Anaemia; Idiopathic Scoliosis; Blood - Anaemia; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618000917235
• Lead Sponsor: Dr Rebecca Munk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age <18 years
- Diagnosed with adolescent idiopathic scoliosis
- Requiring posterior spinal fusion surgery of greater than or equal to 6 vertebral levels or other spinal fusion surgery associated with significant blood loss as determined by the surgical team
- Diagnosis of iron deficiency (ferritin <30mcg/L without anaemia or ferritin <100mcg/L with anaemia (Hb <120g/L))
- Ability to take oral medication and be willing to adhere to the oral iron regimen
- Willingness to attend hospital to undergo intravenous cannulation as required for the intravenous iron regimen
Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Current use of iron supplements
Pregnancy or lactation
Known allergic reactions to components of the IV ferric carboxymaltose or oral iron supplements
Significant medical co-morbidity such as neuromuscular disease, severe anaemia, cardiac disease, significant respiratory disease or impairment
Significant needle phobia
Hypophosphataemia, hypoparathyroidism, low vitamin D levels

Study & Design

• Study Type: Interventional
• Study Design: Not specified