CRIMSON STRIPES
Research type
Research Study
Full title
A Comparison of Available and Novel Methods for Assessing Iron Status and Predicting Response to Parenteral Iron Replacement in Patients with Probable Iron-deficiency-Anaemia.
IRAS ID
279108
Contact name
David Tucker
Contact email
Sponsor organisation
Royal Cornwall Hospital
Clinicaltrials.gov Identifier
NCT, ClinicalTrials.gov
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
Pre-operative anaemia (POA) in patients preparing for elective surgery is common and correction of this has obvious benefits. The commonest causes are anaemia of chronic disease (ACD), iron-deficiency (IDA) and functional iron-deficiency (FID). These forms of anaemia are often difficult to distinguish clinically or by readily available laboratory tests.
Iron deficiency anaemia and FDA are often correctable pre-operatively by administration of oral or parenteral iron. Anaemia of chronic disease is less responsive to oral iron and requires other strategies. This is important because parenteral (intravenous) iron is expensive (c. £800 per dose) and requires both nursing and outpatient resuscitation facilities to administer. Oral iron is cheap (£1s per course), safe and convenient from a healthcare resources perspective.
Therefore identification of IDA and FID and their distinction from ACD before elective surgery is important to guide treatment, predict response and direct other therapies.
There is no clear consensus on the best method for assessing iron status or predicting response to iron replacement apart from assessing bone marrow iron stores which is too invasive for routine use. All currently available methods have well described limitations (Fletcher et al. 2021)
This prospective cohort study aims to identify the best available method from an array of tests to predict a response to parenteral iron in patients with pre-operative anaemia which meets the criteria for probable or possible iron-deficiency.
The study is a pre-test / post-test study design that will correlate the results of an array of tests against a change in haemoglobin concentration 4-10 weeks after parenteral iron replacement in patients identified as probably or possibly iron deficient at pre-operative assessment for elective surgery. These data will be used to determine which test or combination of tests is the most reliable guide to iron-status and has the best predictive value for response to parenteral iron.REC name
London - Bloomsbury Research Ethics Committee
REC reference
23/LO/0903
Date of REC Opinion
10 Nov 2023
REC opinion
Unfavourable Opinion