Preoperative Intravenous Iron to Treat Anaemia in Major Surgery
NCT ID: NCT01692418
Last Updated: 2019-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
487 participants
INTERVENTIONAL
2014-01-31
2019-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ferric carboxymaltose
1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
Ferric carboxymaltose
1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
Normal saline
Normal saline will be administered as an i.v. infusion (100ml normal saline)
Placebo
Normal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
Normal saline
Normal saline will be administered as an i.v. infusion (100ml normal saline)
Interventions
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Ferric carboxymaltose
1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
Normal saline
Normal saline will be administered as an i.v. infusion (100ml normal saline)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing elective major open abdominal surgery.
* The Indication for operation may be for benign or malignant disease.
* Major Surgery is defined as an operation of anticipated duration more than one hour.
3. Screening haemoglobin (Hb) greater than or equal to 90 g/L (9.0 g/dL) but below or equal to 120 g/L (12.0 g/dL) in women or 130 g/L (13.0 g/dL) in men within four weeks of randomisation.
4. Randomisation and administration of study infusion a minimum of 10 days and maximum 42 days before planned operation.
5. Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment.
6. Laboratory data used for determination of eligibility at the baseline visit must not be older than four weeks.
Exclusion Criteria
2. Body weight under 50kg.
3. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or TSAT \> 50%.
4. Known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy).
5. Known hypersensitivity to ferric carboxymaltose (Ferinject®) or its excipients.
6. Temperature \> 37.5 degrees celsius or patient on non-prophylactic antibiotics
7. Known chronic liver disease
8. If clinically indicated for the patient to have LFT's as part of pre-assessment for surgery and this screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of the normal range.
9. Received erythropoietin or i.v. iron therapy in the previous 12 weeks.
10. Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or planned within the next 12 months).
11. Patients with severe asthma or severe allergy (requiring hospitalisation within the last 12 months).
12. Unfit for elective surgery.
13. Pregnancy or lactation.
14. Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
15. Patient involvement in another IMP trial within the previous 4 weeks, prior to randomisation. Involvement in another IMP trial, following randomisation, that may impact on the results of the PREVENTT trial.
18 Years
ALL
No
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Toby Richards, MD FRCS
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Basildon University Hospital
Basildon, , United Kingdom
Blackpool Teaching Hospitals
Blackpool, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Broomfield Hospital
Broomfield, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Queen Elizabeth Hospital
Gateshead, , United Kingdom
Hereford County Hospital
Hereford, , United Kingdom
Hillingdon Hospital
Hillingdon, , United Kingdom
St James's Hospital
Leeds, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
University College London
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
Imperial College Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Marsden
London, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
Pennine Acute Hospitals
Oldham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Peterborough and Stamford Hospitals
Peterborough, , United Kingdom
Salford Royal
Salford, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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References
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Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, Swinson R, Collier T, Dodd M, Dyck LV, Macdougall I, Murphy G, Browne J, Bradbury A, Klein A. Preoperative intravenous iron for anaemia in elective major open abdominal surgery: the PREVENTT RCT. Health Technol Assess. 2021 Feb;25(11):1-58. doi: 10.3310/hta25110.
Richards T, Clevenger B, Keidan J, Collier T, Klein AA, Anker SD, Kelly JD. PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial. Trials. 2015 Jun 4;16:254. doi: 10.1186/s13063-015-0774-2.
Related Links
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Study website
Other Identifiers
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2012-002786-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
10/104/06
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
12/EE/0445
Identifier Type: OTHER
Identifier Source: secondary_id
ISRCTN67322816
Identifier Type: REGISTRY
Identifier Source: secondary_id
12/0246
Identifier Type: -
Identifier Source: org_study_id
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