Preoperative Intravenous Iron to Treat Anaemia in Major Surgery
PREVENTT
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
5 other identifiers
interventional
487
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2014
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2012
CompletedFirst Posted
Study publicly available on registry
September 25, 2012
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJune 3, 2019
May 1, 2019
5.3 years
September 14, 2012
May 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Risk of blood transfusion or death
Co-primary outcome
From randomisation until 30-days following the index operation
Blood transfusion rate (including repeat transfusions)
Co-primary outcome
From randomisation until 30-days following the index operation
Secondary Outcomes (17)
Change in haemoglobin levels
From randomisation to (i) day of index operation, (ii) 8-weeks post index operation and (iii) 6 months post index operation
Total number of units of blood or blood products cross matched, total number of packed red cells and any blood products transfused
From randomisation to 30 days post index operation
Post operative morbidity survey (POMS) outcomes (outcomes will be presence of morbidity defined by the domains of the POMS e.g. gastrointestinal, cardiovascular)
At days 3, 5, 7 and 14 following the index operation
Health-related quality of life: Change in The Multidimensional Fatigue Inventory (MFI) questionnaire total score
From baseline to the 10 day assessment and at 8 weeks and 6 months post operatively
Health-related quality of life: Change in European Quality of Life: 5 Dimensions-5 Levels (EQ-5D-5L) questionnaire total score
From baseline to the 10 day assessment and at 8 weeks and six months post operatively
- +12 more secondary outcomes
Study Arms (2)
Ferric carboxymaltose
EXPERIMENTAL1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
Placebo
PLACEBO COMPARATORNormal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes
Interventions
1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
Normal saline will be administered as an i.v. infusion (100ml normal saline)
Eligibility Criteria
You may qualify if:
- At least 18 years of age and signed written informed consent.
- 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.
- 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.
- Randomisation and administration of study infusion a minimum of 10 days and maximum 42 days before planned operation.
- 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.
- Laboratory data used for determination of eligibility at the baseline visit must not be older than four weeks.
You may not qualify if:
- Patients undergoing laparoscopic surgery.
- Body weight under 50kg.
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or TSAT \> 50%.
- Known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy).
- Known hypersensitivity to ferric carboxymaltose (Ferinject®) or its excipients.
- Temperature \> 37.5 degrees celsius or patient on non-prophylactic antibiotics
- Known chronic liver disease
- 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.
- Received erythropoietin or i.v. iron therapy in the previous 12 weeks.
- Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or planned within the next 12 months).
- Patients with severe asthma or severe allergy (requiring hospitalisation within the last 12 months).
- Unfit for elective surgery.
- Pregnancy or lactation.
- Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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, WC1E 6AU, 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, SO16 6YD, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Related Publications (2)
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.
PMID: 33632377DERIVEDRichards 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.
PMID: 26041028DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Toby Richards, MD FRCS
University College, London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2012
First Posted
September 25, 2012
Study Start
January 1, 2014
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
June 3, 2019
Record last verified: 2019-05