Anaemia Clinical Trial
Official title:
A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Anaemia Undergoing Major Open Abdominal Surgery
Anaemia is a common problem in patients undergoing surgery. About half of patients undergoing
a major operation have anaemia, often a consequence of the disease requiring surgery. Anaemia
causes patients to feel tired and unwell. Anaemia at the time of surgery increases the
requirement for blood transfusion (50% if anaemic compared to only 15% without anaemia). Both
anaemia and blood transfusions are associated with increased complications from surgery,
delayed recovery and prolonged hospital stay. The investigators propose that giving
intravenous iron before operation can be used to correct anaemia in these patients.
Consequently if patients are not anaemic they are less likely to need blood transfusion. Also
patients feel better and their health is improved before their operation they are more likely
to tolerate the surgery, recover faster, be less likely to have complications from surgery
and return home sooner. This will have benefits to the individual patient and also to the NHS
by reducing costs.
Oral Iron tablets are not effective as they take 3-6 months to increase blood levels, the
tablets are often not tolerated as cause constipation or stomach pain, overall only 30-50% of
people continue taking oral iron. A full treatment dose of intravenous iron can be given in
15 minutes with minimal side effects. The effect is to rapidly increase blood counts in 2-4
weeks. The investigators propose that this treatment can be incorporated to patient
preparation pathways for surgery as an outpatient without the need for additional visits to
hospital.
Small studies have suggested a benefit of iron therapy in orthopaedic and gynaecological
surgery. This study will look at 500 patients undergoing major surgery at 20 hospitals in the
UK. The investigators anticipate half of patients treated will have their anaemia corrected
before operation. Patients with anaemia will be identified as part of the routine blood tests
taken preoperatively and invited to take part in the study. Following informed consent, they
will be randomly allocated to receive either intravenous iron or a placebo infusion of
saline. Intravenous iron is a dark liquid given continuously into a vein over 15 minutes. To
ensure neither doctor nor patient knows which treatment is being given both infusions will be
prepared and administered by an unblinded authorised person via a black bag through black
tubing. There will be no other changes to the patient's normal treatment.
The main aim of this study is to assess if intravenous iron will reduce the need for blood
transfusion in the time period around the operation. Further outcome measures will include;
patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes
will be assessed both during hospital stay and after the patient has been discharged. The
trial will be run through a Clinical Trials Unit with considerable experience in conducting
large trials. The team has a large range of experience in anaemia management and assessment
of complications, quality of life and the cost of health care.
The main aim of this study is to assess if intravenous iron will reduce the need for blood
transfusion in the time period around the operation. Further outcome measures will include;
patient-reported quality of life, complications, length of hospital stay, and cost. Outcomes
will be assessed both during hospital stay and after the patient has been discharged. The
trial will be run through a Clinical Trials Unit with considerable experience in conducting
large trials. The team has a large range of experience in anaemia management and assessment
of complications, quality of life and the cost of health care.
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