Rapid Iron Infusion study primary outcome dataset
Menzies School of Health ResearchDataset 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.Identifiers
Source Study
Trial name (public)
Rapid Iron Infusion Study- a randomised controlled trial (RCT) of the treatment of iron deficiency anaemia in children (RIIS)Trial acronym
RIIS
Trial ID
ACTRN12617001273370
Purpose
Treatment
Phase
Phase 3 / Phase 4
Funding
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 .... Read more
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 .... Read more
Can healthy volunteers participate?
No
Population
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
Intervention code Treatment: Drugs
Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital
Comparison
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).
Outcomes
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).