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

Dr Rebecca Munk0 个研究点目标入组 34 人开始时间: 2018年5月31日最近更新: 2018年11月12日

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•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
•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

发起方

Dr Rebecca Munk