Rapid Iron Infusion study primary outcome dataset

Menzies School of Health Research

Dataset description

Baseline randomisaton data (Hb, MCV, age gender, primary hospital diagnosis), risk factors at randomisation, randomisation allocation and treatment received, Hb at 1 and 6-9 months follow up, other iron supplementation during follow up.
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Source Study




Phase 3 / Phase 4


Government body,NHMRC

Scientific enquiries

Prof Peter Morris

Brief 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 ....
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Key Inclusion Criteria

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.

Key Exclusion Criteria

1) 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 par ....
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Can healthy volunteers participate?




Sample Size    226

Min. age    No limit

Max. age    6 Years

Sex    Both males and females

Condition category    Childhood Iron Deficiency Anaemia

Condition code    Blood , Diet and Nutrition


Intervention code Treatment: Drugs

Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital


Control group Active

Intramuscular iron injection with dose calculated according to weight and haemoglobin level as per Clinic Manual for Primary Health Care Practitioners in Remote and Indigenous Health Services in Central and Northern Australia (CARPA Standard Treatment Manual).


Outcome: Haemoglobin level
Timepoint: At the time of anaemia requiring additional iron treatment or at the final assessment at 6-9 months post randomisation (whichever is first).

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see