Plain English Summary
Background and study aims
Anaemia is a condition where the body does not have as much haemoglobin or as many red blood cells as it needs. An international consensus statement suggesting the need to treat preoperative anaemia was published in 2016. In this statement, anaemia and non-anaemic iron deficiency (where the body does not have as much iron as it needs) were identified as patient groups that would benefit from the introduction of pre-operative anaemia screening, assessment and treatment. They suggested that patients with low iron levels, with or without anaemia, should be given iron supplementation to enable them to recover from surgery. The benefits of this has been demonstrated in the anaemic population, whereas there is limited research into this for the non-anaemic iron deficient population.
The aim of this trial is to analyse the effect of iron supplementation in non-anaemic iron deficient patients undergoing lower limb arthroplasty.
Who can participate?
Adult non-anaemic iron deficient patients undergoing hip or knee arthroplasty
What does the study involve?
Participants will be randomly allocated to the intervention group or the control group. The intervention group will receive iron supplementation for six months, covering the pre-operative and post-operative phases of their care. They will receive supplementation for 4 weeks prior to their surgery. The control group will receive care as usual. All participants will have blood tests every 4 weeks throughout the trial, along with 3 weeks after surgery. They will also be asked to complete questionnaires 4 weeks after surgery and 3 months after surgery.
What are the possible benefits and risks of participating?
The possible benefit to participants in the intervention group is that iron supplementation may be effective in improving their recovery from surgery. There are no known benefits for the control group. The results of this study may benefit future patients if the treatment is proven to be effective.
Possible risks of participating include the standard risks associated with blood samples and gastrointestinal symptoms of oral iron supplementation. These symptoms include abdominal pain, constipation, diarrhoea, nausea and dark stools.
Where is the study run from?
Northumbria Healthcare NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2018 to May 2020
Who is funding the study?
SALUS Haus (Germany)
Who is the main contact?
Mike Reed
mike.reed@nhs.net
Trial website
Contact information
Type
Public
Primary contact
Prof Mike Reed
ORCID ID
http://orcid.org/0000-0002-6309-2710
Contact details
Northumbria Healthcare NHS Trust
Wansbeck General Hospital
Woodhorn Lane
Northumberland
NE63 9JJ
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ISIDA Protocol 1.0
Study information
Scientific title
ISIDA: Iron Supplementation for non-anaemic Iron Deficiency before lower limb Arthroplasty
Acronym
ISIDA
Study hypothesis
Non-anaemic iron deficient patients undergoing lower limb arthroplasty will benefit from iron supplementation to improve their haemoglobin recovery post surgery, whilst improving anaemia symptoms.
Ethics approval
HRA and Health and Care Research Wales (HCRW), 21/12/2018, ref: 18/NE/0371
Study design
Interventional single centre two-armed randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Non-anaemic iron deficiency
Intervention
Randomisation will be performed using simple randomisation with the algorithm from www.randomization.com. Patients will be randomised to receive either the intervention or the control.
The intervention arm will receive oral iron supplementation with Foradix mit Eisen (36.8 mg oral iron daily) for 6 months from the point of inclusion, which includes the preoperative and postoperative phases of care.
The control arm will receive no intervention and will have care as usual.
All patients will have blood sampling at 3 weeks post surgery, and at 4 weekly intervals during the trial to test for haemoglobin, C-reactive protein and ferritin levels.
From enrollment in the trial, participants will have blood samples taken every 4 weeks up to 6 months, and will be asked to complete questionnaires 4 weeks after surgery and 3 months after surgery.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Haemoglobin recovery, assessed using blood samples taken at the baseline and 3 weeks after surgery
Secondary outcome measures
1. Length of hospital stay, determined using the patient administration system throughout the study
2. Transfusion rate and number of units transfused, assessed using the transfusion database after 30 days
3. Adverse events (including all cause morbidity and mortality, assessed using patient clinical notes after 30 and 90 days
4. Full blood count (FBC), C-reactive protein (CRP) and ferritin levels, assessed using a blood test every 4 weeks throughout the 6 month trial
5. Readmission within 30 days of surgery, assessed using the patient administration system up to 30 days after surgery
6. Inpatient deep vein thrombosis (DVT) or pulmonary embolism (PE) within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery
7. Pneumonia within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery
8. Cerebrovascular incident within 30 days of surgery, assessed using patient clinical notes up to 30 days after surgery
9. Myocardial infarction within 30 days
, assessed using patient clinical notes up to 30 days after surgery
10. Fatigue, assessed using the FACIT Fatigue Scale 4 weeks after surgery
11. Quality of life, assessed using the EQ-5D-5L questionnaire 3 months after surgery
Overall trial start date
01/05/2018
Overall trial end date
31/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Undergoing primary knee or hip replacement surgery
2. Aged over 18 years
3. Non-anaemic iron deficiency, diagnosed using the following criteria:
3.1. Haemoglobin levels >12 for women and >13 for men
3.2. Ferritin levels <50
4. Not already be taking regular oral iron
5. Provide informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
188 research participants, 94 in each trial arm
Participant exclusion criteria
1. Lack capacity to consent to inclusion in the trial
2. Refusal to participate
3. Known allergy/intolerance to any iron supplementation treatment option
4. Pregnancy
5. Listed for surgery within four weeks of commencing iron supplementation
Recruitment start date
18/04/2019
Recruitment end date
30/11/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northumbria Healthcare NHS Foundation Trust
Research and Development
North Tyneside General Hospital
Rake Lane
North Shields
Northumberland
NE29 8NH
United Kingdom
Sponsor information
Organisation
Northumbria Healthcare NHS Foundation Trust
Sponsor details
Research and Development Department
North Tyneside General Hospital
Rake lane
North Shields
NE29 8NH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
SALUS Haus (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication will be sought in an international journal on the primary and secondary outcome data and in a PhD Thesis. Outcomes will be shared at scientific meetings
IPD sharing statement:
Anonymised raw data from the primary and secondary outcomes will become available after publication. This may be shared with researchers for future research purposes and access will be assessed on an individual basis. Patients have provided consent for anonymised data sharing for the purpose of future research.
Intention to publish date
01/03/2021
Participant level data
Available on request
Basic results (scientific)
Publication list