ISIDA Iron Supplementation for Iron Deficiency during Arthroplasty
Research type
Research Study
Full title
Effectiveness of iron supplementation in the non-anaemic iron deficient patient population undergoing lower limb arthroplasty, A Randomised controlled trial.
IRAS ID
256708
Contact name
Mike Reed
Contact email
Sponsor organisation
Northumbria Healthcare NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
The aim of this trial is to analyse the effect of iron supplementation in non-anaemic iron deficient patients undergoing lower limb arthroplasty. Patients with a normal haemoglobin (greater than 12 in women and 13 in men), who are deemed to be iron deficient (Ferritin below 50) will be recruited to this randomised controlled trial. 188 patients will be randomised 1 to 1 to receive oral iron supplementation or no intervention for six months duration, covering preoperative and postoperative phases of care. All patients will have blood tests 4 weekly throughout the trial and a sample 3 weeks postop. To ease patient burden, blood tests will be arranged with the patient in home or hospital clinic. All participants must receive at least 4 weeks of supplementation prior to surgery to be eligible for the trial. The hypothesis being that patients with reduced overall iron stores will benefit from iron supplementation to enable their haemoglobin to recover after surgery.
Primary Outcome: Hb at 3 weeks postoperative
Secondary Outcomes
• Length of hospital stay (midnights in hospital).
• Transfusion Rate and number of units transfused up to 30 days
• Adverse events (including all cause morbidity and mortality at 30 and 90 days)
• FBC, CRP and Ferritin every 4 weeks throughout the six month trial.
• Readmission within 30 days of surgery
• Inpatient DVT/PE within 30 days of surgery
• Pneumonia
• Cerebrovascular incident
• Myocardial infarction
STUDY WITHIN A TRIAL
The aim of this study within a trial is to analyse response rates and quality using two different methods to administer post operative quality of life questionnaires.
Patients will be randomised to postal and telephone follow-up initially, with further contact if necessary to improve response or completion rate.
Patients randomised to postal follow-up, will receive an anaemia screening questionnaire (FACIT Fatigue) at 4 weeks and QOL (eq 5d 5l) at 3 months to be completed and returned. Patients randomised to telephone follow-up, will receive telephone calls to complete the same questionnaires.REC name
North East - York Research Ethics Committee
REC reference
18/NE/0371
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion