Rapid Iron Infusion Study- a randomised controlled trial (RCT) of the treatment of iron deficiency anaemia in children (RIIS)
Rapid ferric carboxymaltose infusion (Ferinject) for Iron Deficiency Anaemia in Aboriginal children: a randomised controlled trial
Menzies School of Health Research
226 participants
Sep 13, 2017
Interventional
Conditions
Summary
The Rapid Iron Infusion Study (RIIS) is a randomised controlled trial for Aboriginal children with severe iron deficiency anaemia, The aim is to assess whether a single intravenous infusion of ferric carboxymaltose (Ferinject) given over 15 minutes in children prior to their discharge from hospital compared to the standard treatment with intramuscular iron injections as per CARPA Manual, will improve haemoglobin levels and reduce the risk of further anaemia. The potential benefits of rapid iron infusions include higher haemoglobin levels, fewer painful intramuscular injections, better adherence to recommended treatment, and less use of primary health care resources.
Eligibility
Inclusion Criteria1
- Aboriginal or Torres Strait Islander children with Iron deficiency anaemia (a haemoglobin level (Hb) <110g/L and mean cell volume (MCV) <75fL), will be eligible to participate in the randomised trial if the treating clinician recommends parenteral iron treatment.
Exclusion Criteria1
- parenteral iron treatment or blood transfusion within the last 4 weeks; 2) known iron overload, haemoglobinopathy, haemolytic anaemia, aplastic anaemia, lymphoproliferative disease or current cancer treatment; 3) febrile >38 degree centigrade or very unwell or receiving phosphate supplementation at the time of discharge; 4) lack of access to a primary health provider in the NT; 5) allergy or hypersensitivity to Ferinject or any of its excipients; 6) known serious hypersensitivity to other parenteral iron products; 7) severe asthma, eczema or allergies; 8) not planning to remain resident in the NT for 12 months.
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Interventions
Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital
Locations(2)
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ACTRN12617001273370