AnaemiaPhase 3PREVENTTNCT01692418
Preoperative Intravenous Iron to Treat Anaemia in Major Surgery
A Phase 3 study testing Ferric carboxymaltose and Normal saline in people with Anaemia, run by University College, London at 28 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaemia
- What is being tested?
- Ferric carboxymaltose and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 487 participants
- Where
- 28 sitesUnited Kingdom
- Study dates
- Jan 2014to May 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United Kingdom28 sites
Basildon University Hospital
Basildon
Blackpool Teaching Hospitals
Blackpool
Southmead Hospital
Bristol
Broomfield Hospital
Broomfield
Countess of Chester Hospital
Chester
Russells Hall Hospital
Dudley
Royal Infirmary of Edinburgh
Edinburgh
Queen Elizabeth Hospital
Gateshead
Hereford County Hospital
Hereford
Hillingdon Hospital
Hillingdon
St James's Hospital
Leeds
Aintree University Hospital
Liverpool
Liverpool Women's Hospital
Liverpool
University College London
London, WC1E 6AU
Guy's and St Thomas' Hospital
London
Imperial College Hospital
London
King's College Hospital
London
Royal Marsden
London
James Cook University Hospital
Middlesbrough
Queen's Medical Centre
Nottingham
Pennine Acute Hospitals
Oldham
John Radcliffe Hospital
Oxford
Peterborough and Stamford Hospitals
Peterborough
Salford Royal
Salford
Northern General Hospital
Sheffield
Southampton General Hospital
Southampton, SO16 6YD
Morriston Hospital
Swansea
Royal Cornwall Hospital
Truro
About this study
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.
Read more
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.
- Conditions
- Anaemia
- Being tested
- Ferric carboxymaltose, Normal saline
- Keywords
- Anaemia, Blood transfusion, Surgery, Iron, Ferric carboxymaltose
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
Normal salineDrug
Normal saline will be administered as an i.v. infusion (100ml normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Experimental | 1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes Receives: Drug: Ferric carboxymaltose; Drug: Normal saline |
| Placebo | Placebo comparator | Normal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of blood transfusion or death
Co-primary outcome
Measured: From randomisation until 30-days following the index operation
Blood transfusion rate (including repeat transfusions)
Co-primary outcome
Measured: From randomisation until 30-days following the index operation
Secondary outcomes (17)
Change in haemoglobin levels
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
Health-related quality of life: Change in Single Question Outcome Measure (SQOM)
Measured: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
Health resource utilisation
Measured: Pre-admission, during admission for index operation, 8 weeks post index operation, and 6 months post index operation
Calculated direct, indirect and total costs for the NHS from two perspectives (payer's and societal perspective)
Measured: From baseline to 6 months post-surgery
Cost effectiveness of treatment options using relevant effectiveness parameters
Measured: From baseline to 6 months post-surgery
Any reaction or side effect from trial therapy
Any reaction or side effect from whole blood or blood product, transfusion reaction
Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Length of hospital stay
Mortality
Measured: 8 weeks and 6 months post-operatively
Readmission
Measured: Within 8 weeks and within 6 months of the index operation
Blood transfusion
Measured: From randomisation to 8 weeks and 6 months post-operatively
Change in e-GFR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJan 2014
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toby Richards, MD FRCS, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692418
- Sponsor's protocol ID
- 12/0246
- Other IDs
- 2012-002786-35, 10/104/06, 12/EE/0445, ISRCTN67322816
- Acronym
- PREVENTT
- Status last verified
- May 2019
- First submitted
- 14 Sep 2012
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33632377Richards 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.
PubMed 26041028
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01692418
- Acronym / sponsor ID
- PREVENTT / 12/0246
- Conditions
- Anaemia
- Keywords
- Anaemia, Blood transfusion, Surgery, Iron, Ferric carboxymaltose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric carboxymaltose, Drug: Normal saline1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes |
| Placebo | Placebo comparator | Drug: Normal salineNormal saline will be administered as an i.v. infusion (100ml normal saline) over a minimum of 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age and signed written informed consent.
- Patients undergoing elective major open abdominal surgery.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseAlso: Ferinject1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline) | Drug | Ferric carboxymaltose |
| Normal salineNormal saline will be administered as an i.v. infusion (100ml normal saline) | Drug | Ferric carboxymaltose, Placebo |
Primary outcome
Risk of blood transfusion or death
Time frame: From randomisation until 30-days following the index operation
Co-primary outcome
Blood transfusion rate (including repeat transfusions)
Time frame: From randomisation until 30-days following the index operation
Co-primary outcome
17 secondary outcomes
Change in haemoglobin levels
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
Health-related quality of life: Change in Single Question Outcome Measure (SQOM)
Time frame: From baseline to the 10 day assessment and at 8 weeks and six months post operatively
Health resource utilisation
Time frame: Pre-admission, during admission for index operation, 8 weeks post index operation, and 6 months post index operation
Calculated direct, indirect and total costs for the NHS from two perspectives (payer's and societal perspective)
Time frame: From baseline to 6 months post-surgery
Cost effectiveness of treatment options using relevant effectiveness parameters
Time frame: From baseline to 6 months post-surgery
Any reaction or side effect from trial therapy
Any reaction or side effect from whole blood or blood product, transfusion reaction
Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Length of hospital stay
Mortality
Time frame: 8 weeks and 6 months post-operatively
Readmission
Time frame: Within 8 weeks and within 6 months of the index operation
Blood transfusion
Time frame: From randomisation to 8 weeks and 6 months post-operatively
Change in e-GFR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Derived from this study: PubMed 33632377Richards 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.
- Derived from this study: PubMed 26041028Richards 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby Richards, MD FRCS principal investigator
University College, London
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric carboxymaltose and Normal saline in people with Anaemia, run by University College, London at 28 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of blood transfusion or death (time frame: From randomisation until 30-days following the index operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692418, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.