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POSTVenTT RCT - Post-operative variability in anaemia treatment: a pilot randomised controlled trial.

A two-arm, parallel-group, open label, randomised controlled feasibility trial assessing the effect of intravenous iron versus no treatment on haemoglobin concentration in anaemic patients undergoing abdominal surgery.

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000669695
Acronym
POSTVenTT
Enrollment
100
Registered
2023-06-21
Start date
2023-09-04
Completion date
2023-10-27
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Anaemia affects nearly a quarter of the world, and is common in surgical patients with a third of patients presenting with preoperative anaemia and three quarters of patients discharged from hospital with anaemia. The World Health Organisation defines anaemia as an insufficient circulating red cell mass, with a haemoglobin (Hb) concentration of < 130 g.l-1 for men and < 120 g.l-1 for women. Peri-operative anaemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogenic blood transfusions, which is an independent risk for poorer patient outcomes. The most common cause of preoperative anaemia is iron deficiency, which can be caused by reduced or impaired dietary iron absorption, chronic blood loss, or disruption of normal iron metabolism due to co-morbidities or inflammation, aetiologies commonly seen in patients undergoing major abdominal surgery, which causes an increase in hepcidin production resulting in functional iron deficiency, and reduced red cell production. Surgical anaemia can be due to chronic disease, blood loss at operation or secondary to surgical inflammation. Cytokines (particularly IL-6) upregulate hepcidin, the master regulator of iron homeostasis, which prevents iron transport leading to failure of dietary iron absorption, and sequestration of iron within macrophages. This leads to functional iron deficiency and subsequently anaemia of chronic disease. The efficacy of intravenous iron therapy may be impacted by the balance between the inflammatory modulation of iron sequestration and bone marrow suppression with the hypoxic drive for erythrogenesis. Although efficacy of intravenous iron was shown in the IRONMAN trial - performed in patients following ICU admission - and the PREVENTT trial in preoperative patients, the one size all approach may not be precise. Consequently, in the surgical pathway, the optimal timing and modality is unknown. The outcome of this research will provide evidence on the efficacy of post-operative iron administration to treat anaemia in surgical patients. The study will also provide feasibility data to help support a larger future trial.

Interventions

Active: Intravenous iron infusion Ferric carboxymaltose 1000 mg given intravenously Intravenous iron will be administered once only postoperatively in accordance with local hospital guidelines. Adherence will be monitored in accordance with local hospital guidelines.

Sponsors

VERITAS Collaborative
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who meet the following criteria: 1. Adult (greater than or equal to 18 years of age) 2. Patients who have undergone major abdominal surgery during the study recruitment periods 3. Anaemia (Hb <130g/L in males, and <120g/L in females) demonstrated on blood tests performed either during or after the procedure

Exclusion criteria

Patients who, at the start of treatment, meet any of the following criteria are not eligible for the study: 1. Erythropoietin or IV iron in the previous 4 weeks 2. Known hypersensitivity to iron or its excipients 3. Known chronic liver disease 4. Known family history of haemochromatosis or Transferrin Saturation (TSATS) >50% 5. Pregnancy or lactation 6. Unable to provide written informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 25, 2026