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South African Paediatric Surgical Outcomes Study 2 (SAPSOS2)

Primary Purpose

Paediatric Surgery, Anaemia, Iron Deficiency Anemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ferrous gluconate syrup or ferrous fumarate/folic acid tablets
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paediatric Surgery

Eligibility Criteria

6 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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 6 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Iron-deficiency anaemia

    Arm Description

    Participants will receive oral iron supplementation for a minimum of 6 weeks prior to surgery

    Outcomes

    Primary Outcome Measures

    Delta Haemoglobin = Change in average haemoglobin pre- and post- oral iron supplementation

    Secondary Outcome Measures

    Incidence of iron-deficiency anaemia

    Full Information

    First Posted
    January 3, 2023
    Last Updated
    January 11, 2023
    Sponsor
    University of Cape Town
    Collaborators
    University of Stellenbosch, University of KwaZulu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05681871
    Brief Title
    South African Paediatric Surgical Outcomes Study 2
    Acronym
    SAPSOS2
    Official Title
    South African Paediatric Surgical Outcomes Study-2 (SAPSOS-2). 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 16, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cape Town
    Collaborators
    University of Stellenbosch, University of KwaZulu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Studies in both paediatric and adult patients have shown an association between preoperative anaemia and increased postoperative morbidity and mortality, and transfusion rates. The incidence of preoperative anaemia in the secondary analysis of the SAPSOS cohort of children who underwent noncardiac surgery was 46.2%. IDA has been shown to represent up to 30% of preoperative anaemia in adults. Iron deficiency and IDA are of even greater concern in children, because of the negative impact it may have on cognitive performance. A recent Cochrane review on the role of preoperative iron in reducing perioperative blood transfusion in adult patients found no significant reduction in the administration of allogeneic blood transfusion in patients who had received preoperative iron compared with those who did not. These findings were supported by the Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT) trial which found no difference in blood transfusion or death between the patients who did and did not receive intravenous iron. However, these findings have generated much discussion in the literature and concerns have been raised about the clinical application of this study. The mean haemoglobin (Hb) difference between the two groups post intervention (0.47g.dl-1) highlights the need for greater understanding of the impact of an intervention on the absolute or relative increase in Hb when designing trials looking at the impact of iron treatment on perioperative outcomes. Dosing regimens of preoperative oral iron varies widely between studies further complicating the ability to draw conclusions of the role of oral iron in the treatment of preoperative anaemia. In contrast with the findings of the Cochrane review and the PREVENTT trial, a meta-analysis of patient blood management programme (PBM) studies, many of which include preoperative iron treatment as a component, found that there was a reduction in exposure to red cell transfusions. Although, the meta-analysis also found the implementation of PBM was not associated with a reduction on in-hospital mortality or 30-day mortality, there was no additive benefit from multiple interventions and no trial showed that PBM were cost-effective. Not included in this meta-analysis were recently published studies on the implementation of preoperative anaemia screening clinics in adults in elective colorectal surgery and major surgery which demonstrated reductions in red cell transfusions, length of stay, and net costs in patients with IDA who were treated with preoperative intravenous iron. Similarly, a large study from Western Australia reported significant reductions in cost associated with the use of blood products, and improved patient outcomes, after implementation of a PBM. Studies investigating the impact of increasing preoperative Hb on perioperative outcomes in children are primarily focused on blood loss and blood transfusion rates in surgery in which significant bleeding and frequent blood transfusion are anticipated and most of the children in these studies received preoperative erythopoeitin. The impact of preoperative oral iron as a stand-alone intervention to increases preoperative Hb are limited to 2 studies. A single retrospective study has reported on the impact of the introduction of preoperative oral iron without erythropoeitin (EPO) in children undergoing spinal surgery. They found a significant difference in intraoperative transfusion rates in patients who received a longer duration of preoperative oral iron therapy. The major limitation of the study was a lack of preintervention Hb, precluding the ability to assess the effect of iron supplementation on delta Hb. A subsequent study reviewing the impact of preoperative oral iron in paediatric cardiac patients found that iron supplementation resulted in an increase in preoperative Hb levels which was associated with reduced red blood cell transfusion volumes. Given the high incidence of preoperative anaemia in children having surgery in South Africa in the public sector and its association with poorer postoperative outcomes, it is important to assess the feasibility of a pragmatic intervention to treat preoperative anaemia in the context of a resource-constrained setting. Although intravenous iron in combination with EPO may be more effective and have fewer side effects, oral iron is relatively inexpensive and widely available in South Africa. Regular deworming may also play an important role in the treatment of preoperative anaemia and has been shown to be an effective intervention to increase baseline Hb in school age children from low- and middle- income countries. We hypothesise that the implementation of preoperative anaemia screening and treatment of anaemic patients with a minimum of 6 weeks supplementation with oral iron will have a clinically significant effect on increasing the Hb in patients with preoperative IDA. STUDY OBJECTIVE To evaluate the efficacy of oral iron supplementation in children diagnosed with preoperative IDA undergoing noncardiac surgery. STUDY DESIGN Pre and post- South African multi-centre interventional study of oral iron supplementation to treat IDA in paediatric patients (age >6 months and <16 years) admitted to participating hospitals undergoing elective non-cardiac surgery. The intention is to present a representative sample of paediatric surgical patients with preoperative anaemia. This study will run from January 2023 until July 2023. ETHICS APPROVAL Ethics approval will be in place at each hospital site prior to recruitment of patients. Informed consent, and assent where appropriate, must be obtained for each participant enrolled in the study. IMPORTANCE OF STUDY Preoperative anaemia is associated with significant morbidity and mortality. The information gained from this study will contribute to a greater understanding of the incidence of preoperative IDA in children in South Africa and give insight into the feasibility and efficacy of oral iron supplementation to treat preoperative IDA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paediatric Surgery, Anaemia, Iron Deficiency Anemia, Iron, Prospective Studies, Interventional Studies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective interventional quasi-experimental pre-post study South African multi-centre
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    420 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Iron-deficiency anaemia
    Arm Type
    Experimental
    Arm Description
    Participants will receive oral iron supplementation for a minimum of 6 weeks prior to surgery
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Ferrous gluconate syrup or ferrous fumarate/folic acid tablets
    Intervention Description
    Oral iron supplementation dosed based on body weight
    Primary Outcome Measure Information:
    Title
    Delta Haemoglobin = Change in average haemoglobin pre- and post- oral iron supplementation
    Time Frame
    6-12 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of iron-deficiency anaemia
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 6 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heidi M Meyer, MBChB
    Phone
    +27(0)6585813
    Ext
    5813
    Email
    heidi.meyer@uct.ac.za
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanel Administrator
    Phone
    +27 67 429 2053
    Email
    it@safesurgery.co.za
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Heidi M Meyer, MBChB
    Organizational Affiliation
    University of CapeTown
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    South African Paediatric Surgical Outcomes Study 2

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