South African Paediatric Surgical Outcomes Study 2
SAPSOS2
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
1 other identifier
interventional
755
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2023
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedStudy Start
First participant enrolled
February 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedSeptember 18, 2025
September 1, 2025
2.3 years
January 3, 2023
September 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delta Haemoglobin = Change in haemoglobin pre- and post- oral iron supplementation
g/dL
4-12 weeks
Secondary Outcomes (1)
Incidence of iron-deficiency anaemia
24 months
Study Arms (1)
Iron-deficiency anaemia
EXPERIMENTALParticipants will receive oral iron supplementation for a minimum of 4 weeks prior to surgery
Interventions
Oral iron supplementation dosed based on body weight
Eligibility Criteria
You may qualify if:
- Age \> 6 months to \<16 years
- Noncardiac surgery
- Elective surgery
- Anaemic as per World Health Organisation criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cape Townlead
- University of Stellenboschcollaborator
- University of KwaZulucollaborator
Study Sites (2)
Tygerberg Hospital
Cape Town, Western Cape, 7505, South Africa
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, 7700, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi M Meyer, MBChB
University of CapeTown
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Specialist Anaesthetist, Division of Paediatric Anaesthesia, Department of Anaesthesia & Perioperative Medicine
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 12, 2023
Study Start
February 9, 2023
Primary Completion
May 31, 2025
Study Completion
May 31, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
- Access Criteria
- Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact researchcontracts@uct.ac.za
Data sharing agreement has been finalised between the University of Cape Town and Professor Susan Goobie and Dr. Steven Staffa at Boston Children's Hospital. Purpose of this agreement is for statistical analysis and manuscript development. All shared data will undergo de-identification. Shared data includes eligibility, consent, reasons for exclusion, and de-identified record IDs, patient demographics, comorbidities, deworming status, planned date of surgery, hemocue results, pre-intervention formal Hb, MCV, reticulocyte count, CRP, ferritin levels, TSAT, information regarding medication compliance and any experienced side-effects, date of repeat Hb and post-intervention formal Hb, and serious adverse events.