Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial.
Study Goal
The researchers aimed to assess the feasibility of a large RCT to evaluate intravenous iron therapy (IVIT) for improving patient well-being following orthopaedic injury, focusing on clinical and patient-reported outcomes.
Results Summary
The abstract does not report specific results regarding Iron's effects, as it describes a pilot study focused on feasibility metrics (enrolment, follow-up, adverse events) rather than efficacy outcomes.
Population
Adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7-11 g/dL within 7 days postoperatively.
Effective Dosage
Single dose infusion of low-molecular weight iron dextran (1000 mg).
Duration
Follow-up for 3 months.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
intravenous iron therapy (IVIT) | increase | patient well-being | patients following orthopaedic injury | - | to improve | #1 |
low-molecular weight iron dextran (1000 mg) | increase | clinical outcomes (resolution of anaemia and functional iron deficiency) | traumatically injured orthopaedic patients with acute blood loss anaemia | - | to measure the effect of | #2 |
low-molecular weight iron dextran (1000 mg) | increase | patient-reported outcomes (fatigue, physical function, depression and quality of life) | traumatically injured orthopaedic patients with acute blood loss anaemia | - | to measure the effect of | #3 |
low-molecular weight iron dextran (1000 mg) | increase | translational measures of immune cell function | traumatically injured orthopaedic patients with acute blood loss anaemia | - | to measure the effect of | #4 |
INTRODUCTION: Orthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation. METHODS AND ANALYSIS: This single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7-11 g/dL within 7 days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3 months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function. ETHICS AND DISSEMINATION: This study has ethics approval (Oregon Health & Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05292001; ClinicalTrials.gov.