Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital

Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital (LGH).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001256965

Enrollment

154

Registered

2011-12-07

Start date

2012-01-31

Completion date

2015-11-06

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study is a prospective randomised trial screening elective surgical patients from both sexes with full blood count and iron studies during the study period. These patients will be offered to take part in the study at the Launceston General Hospital (LGH). In our interim analysis for a similar orthopaedic trial, approximately 15-20% of patients presented with low haemoglobin in this cohort of patients. This study is to be conducted by staff working within the Launceston General Hospital, (LGH) recruiting patients from the Northern half of the state of Tasmania and will be a collaborative project involving the Departments of Clinical Haematology, Anaesthesia, Surgery and Pathology as well as University of Tasmania as part of their collaborative work. It has agreement with the Admissions department of the hospital in regards to notification of prospective patients and their hospital booking dates. All patients who offered to participate in the trial will be counselled on any side effects of the iron therapy. If participants decide to withdraw from the study at any time, it will have no effect on their care or procedure.

Interventions

The patients with anaemia will be randomised between oral iron sulphate of 325 mg daily until the time of operation and a single iron carboxymaltose infusion 15mg/Kg body weight once only. The control group will receive treatment as per standard care at the LGH. Outcome measures: by Hb and iron studies.

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

Inclusion criteria

The inclusion criteria for anaemic patients in the study will be a haemoglobin level above 85g/L, but < normal level in males and in females as measured by an accredited LGH pathology laboratory in addition to low iron stores.

Exclusion criteria

1. Presence of a specific cause for anaemia apart from haematinic deficiency 2. Haematological disorders or other malignancies associated with anaemia

Outcome results