Correction of preoperative iron deficiency in children undergoing elective spinal fusion. A Randomised control trial of Intravenous Iron vs. Oral Iron therapy.
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 Munk
34 participants
Dec 1, 2018
Interventional
Conditions
Summary
This study aims to evaluate whether intravenous iron is superior to oral iron in correcting preoperative iron deficiency in children undergoing posterior spinal fusion surgery. As there is often a limited time window between patients being booked for surgery (and undergoing preoperative screening) and their surgical date it is important to determine what is the more effective treatment method. The null hypothesis states that there is no difference between oral and IV iron therapy in the incidence of severe anaemia at the time of discharge following elective spinal fusion surgery. The primary outcome measure is the incidence of severe anaemia (haemoglobin <100g/L) at the time of discharge from hospital.
Eligibility
Inclusion Criteria10
- 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 Criteria7
- 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
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Interventions
Patients who are found to be iron deficient prior to their elective spinal surgery will be randomised to receive either oral or intravenous iron therapy preoperatively. Those randomised to intravenous iron (intervention will receive a weight appropriate dose (see below) of ferric carboxymaltose administered as an intravenous infusion diluted in 0.9% Sodium Chloride as per manufactures guidelines. This dose will be administered once 3-5 weeks preoperatively unless the dose exceeds 20mg/kg or 1000mg in which case the patient will receive a divided dose timed one week apart. Using the Ganzoni Formula to estimate total iron deficit: Total iron dose (mg iron) = Weight(kg) x (Target Hb* - Actual Hb)(g/L) x 0.24 + Iron for stores** Where: * Target Hb <35kg = 130g/L >35kg = 150g/L ** Iron for stores <35kg = 15mg/kg >35kg = 500mg The above calculated dose will be administered in the Medical Day Unit according to the CMI and manufactures guidelines. Compliance and tolerably of intravenous iron will be documented directly in the patient medical notes.
Locations(1)
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ACTRN12618000917235