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Influence of Non-Anaemic Iron Deficiency on Outcomes Following Cardiac Surgery

A prospective, observational study to determine if non-anaemic iron deficiency increases hospital stay and decreases days alive and at home in patients undergoing elective cardiac surgery.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000185268
Acronym
IDOCS
Enrollment
480
Registered
2018-02-05
Start date
2018-02-22
Completion date
2021-02-11
Last updated
2023-05-01

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

Conditions

None listed

Brief summary

Adequate iron stores are essential for the ability of the body to produce new red blood cells, and the key component of those red blood cells, haemoglobin. A low blood concentration of haemoglobin is referred to as “anaemia”, and is often due to low iron stores, or an inability for the bone marrow to access them. This latter phenomenon is referred to as “iron deficiency”. Iron deficiency and anaemic may exist in a patient separately, or together. A combination of the two is termed “iron deficiency anaemia”, and patients with the condition are said to be “anaemic”. Iron deficiency anaemia has long been associated with worse outcomes for patients undergoing cardiac surgery. Compared to a normal person, the patient with iron deficiency anaemia has a higher risk of requiring a blood transfusion, sustaining a kidney injury, or dying following their operation. There is another group that, up until now, has been poorly studied: those patients who are iron deficient, but not anaemic. Whilst these patients may have a normal haemoglobin concentration in their blood prior to surgery, inevitable blood loss during surgery and the inflammation during and afterwards causes the haemoglobin concentration to fall. If the patient has inadequate stores of iron, or is unable to access those stores, these patients will be unable to increase their production of haemoglobin. Hypothetically, these patients are at risk of many of the complications that patients with anaemia prior to their operation will face. However, because this research question is yet to be formally studied, it is not known whether or not this is correct. Proposed trial and investigators The IDOCS study has been designed to test this theory. Patients with iron deficiency, but who are not anaemic before their operation will be followed during and after their surgery and compared to a cohort of normal patients (who are iron replete and not anaemic) as a reference point. If the trial hypothesis is correct, patients who are iron deficient but not anaemic will have worse outcomes than those patients who are not anaemic and iron replete. IDOCS will be undertaken at two major tertiary hospitals in Melbourne: The Alfred and the Austin Hospital. Significance If the hypothesis of IDOCS is proven, it will identify a new group of patients who are at risk of poor outcomes following cardiac surgery, opens an exciting new frontier in preparing patients for these procedures, and improving survival and reducing complications from the operation.

Interventions

Elective cardiac surgical patients with non-anaemic iron deficiency at time of surgical booking.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

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

Inclusion criteria

Patients scheduled to undergo elective cardiac surgery.

Exclusion criteria

Emergency or inpatient surgery. Pregnancy. Age < 18 years. Known or suspected haemoglobinopathy. Bone marrow disease. Haemochromatosis. End stage renal failure requiring dialysis. Erythropoetin or iron (IV or oral) in the preceding 4 weeks prior to enrolment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026