Iron Deficiency Anemia Clinical Trial
— SAPSOS2Official title:
A South African Multi-centre Pilot Trial to Assess the Feasibility and Clinical Efficacy of Preoperative Oral Iron to Treat Preoperative Iron-deficiency Anaemia in Children Undergoing Elective Noncardiac Surgery
Preoperative anaemia has been shown to be associated with worse outcomes after surgery in both adults and children. Limited research has been done on how common preoperative iron-deficiency anaemia (IDA) is in children and how best to treat it. Oral iron is a relatively cost-effective treatment for IDA. This study aims to show whether giving children with IDA oral iron for 6-12 weeks before their surgery significantly improves their haemoglobin.
Status | Recruiting |
Enrollment | 1100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 16 Years |
Eligibility | Inclusion Criteria: - Age > 6 months to <16 years - Noncardiac surgery - Elective surgery - Anaemic as per World Health Organisation criteria Exclusion Criteria: - Patient or parent refusal - Unable to obtain written consent at the surgical outpatient clinic - Surgery planned within 4 weeks from surgical outpatient visit - Known history of acquired iron overload, family history of haemochromatosis or thalassemia - Known reason for anaemia (e.g., untreated vitamin B12 or folate deficiency or haemoglobinopathy) - Treatment with oral iron, erythropoietin, IV iron therapy or blood transfusion in the previous 12 weeks - Known hypersensitivity to oral iron or other contraindication to oral iron - Temperature > 38.0 °C or receiving non-prophylactic antibiotics - Acute liver failure |
Country | Name | City | State |
---|---|---|---|
South Africa | Red Cross War Memorial Children's Hospital | Cape Town | Western Cape |
South Africa | Tygerberg Hospital | Cape Town | Western Cape |
South Africa | Inkosi Albert Luthuli Central Hospital | Durban | Kwa-Zulu Natal |
South Africa | Greys Hospital | Pietermaritzburg | Kwa-Zulu Natal |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | University of KwaZulu, University of Stellenbosch |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta Haemoglobin = Change in average haemoglobin pre- and post- oral iron supplementation | g/dL | 4-12 weeks | |
Secondary | Incidence of iron-deficiency anaemia | 18 months |
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