Safety of iron polymaltose infusion given over 30 and 15 minutes for treatment of iron deficiency.
Ultrarapid iron polymaltose infusion for iron deficiency anaemia: a pilot safety study
Iouri Banakh
20 participants
Nov 10, 2017
Interventional
Conditions
Summary
Iron deficiency and anaemia are common conditions. They are treated by increasing your body’s iron levels . The most common way is by mouth as an iron tablet or liquid. Some people may need iron to be given directly into the blood through a vein, and this is called an intravenous (IV) iron infusion. An IV iron infusion is used when tablets or liquids do not work for a person or when they cause side effects such as stomach upset. In the past, iron polymaltose (a type of IV iron) was only given as an IV infusion over 4 hours. These days, it can be given faster and safely over 1 hour (for doses up to 1500 mg) thanks to the results of recent studies. Another type of IV iron, ferric carboxymaltose, is frequently used and can be given over just 15 minutes. However, it is more expensive and can only deliver a maximum dose of 1000 mg per week. Most people need around 1500 mg to completely top-up their iron and to last them for months or even up to a year. Previous studies suggest that how quickly IV iron is given has no effect on how well this treatment is tolerated. For this reason, the goal of this study is to test the safety of iron polymaltose given over 30, and then potentially over 15 minutes. Safety results will be compared to the slower infusions and to the other type of IV iron, ferric carboxymaltose. If no difference in safety is found, then this could be a better option because patients can be treated with a complete iron top-up and have it done over a shorter period of time. Infusion centres and hospitals would also benefit with reduced nursing time, larger number of patients treated and reduced direct medication costs. Iron polymaltose has been approved in Australia to treat iron deficiency anaemia since 27 May 1999. However, it is not approved for infusion rates over 15 or 30 minutes. Therefore, it is an experimental method of giving this treatment for iron deficiency anaemia. This means that it must be tested to see if it is as safe as the usual way of giving it over 1 or 4 hours.
Eligibility
Inclusion Criteria3
- Frankston Hospital patients diagnosed with iron deficiency anaemia of any cause requiring iron replacement doses of up to 1500 mg.
- Treating team provided consent for their patient to be approached to participate.
- Patients able to provide informed consent.
Exclusion Criteria4
- Patients requiring doses greater than 1500 mg of iron polymaltose.
- Patients unable to give informed consent.
- Patients unable to read English.
- Treating team declining for their patient to be approached to participate in the study.
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Interventions
The study interventions include intravenous infusion of iron polymaltose up to 1500 mg in 250 mL sodium chloride 0.9% administered at ultrarapid rates: firstly over 30 minutes and then, should no safety concerns arise, over 15 minutes in a second case series. There will be an interim review of the patients who have received the 30 minute infusions, and if these are found to be safe, then the study will progress to enrol patients into 15 minute infusion series. The doses are adjusted based on level of iron deficiency and comorbidities, as well as patient weight and any blood transfusions as per hospital guidelines.
Locations(1)
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ACTRN12617001615370