AMBLE Trial: Iron Deficiency Anaemia in Major Cardiac, Abdominal and VascuLar surgery patients and Effect on functional outcomes

Phase 4

Not yet recruiting

• Conditions: Anaemia; Iron deficiency; Vascular Surgery; Abdominal Surgery; Cardiac surgery; Surgery - Other surgery; Blood - Anaemia

• Registration Number: ACTRN12622001447741
• Lead Sponsor: South Metropolitan Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Perioperative group and Recovery group

Patients who meet the following criteria at the start of treatment are eligible for the study:
1.Adults (greater than or equal to 18 years)
2.Undergoing planned or unplanned (elective/expedited or emergent) cardiac surgery (bypass or valve), abdominal surgery (open or laparoscopic) or vascular surgery (open or hybrid) of the lower limb
3. Anaemia (Hb <130g/L in males and <120g/L) in females
4.Willing and able to undergo follow-up visits

Exclusion Criteria

Perioperative group and Recovery group

Patients who, at the start of treatment, meet any of the following criteria are not eligible for the study:
1.Blood transfusion at operation or blood transfusion in previous 3 months
2.Erythropoietin or intravenous iron in the previous 4 weeks
3.Known hypersensitivity to (ferric carboxymaltose or equivalent) or its excipients
4.Active infection on therapeutic antibiotics
5.Known chronic liver disease
6.Known other cause for anaemia (eg. untreated B12 or folate deficiency or myelodysplasia)
7.Known family history of haemochromatosis or Transferrin saturation (TSATS) >50%
8.Pregnancy or lactation
9.Unable to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified