PREoperative intraVENous iron To Treat anaemia in major surgery (PREVENTT)
- Conditions
- AnaemiaHaematological DisordersOther anaemias
- Registration Number
- ISRCTN67322816
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26041028 2020 results in https://doi.org/10.1016/S0140-6736(20)31539-7 (added 23/09/2020) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33632377/ (added 01/03/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 487
Current inclusion criteria as of 23/04/2015:
1. At least 18 years of age and signed written informed consent
2. Patients undergoing elective major open abdominal surgery
2.1. The Indication for operation may be for benign or malignant disease
2.2 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
Previous inclusion criteria from 24/01/2014 to 23/04/2015:
1. At least 18 years of age and signed written informed consent
2. Patients undergoing elective major open abdominal surgery
2.1. The Indication for operation may be for benign or malignant disease
2.2. Major Surgery is defined as an operation of anticipated duration more than one hour where all or part of an abdominal organ is to be removed (hepatectomy, pancreatectomy procedure, gastrectomy, oesophagectomy, colectomy (total/partial), nephrectomy, cystectomy, hysterectomy).
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) 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
Original inclusion criteria:
1. At least 18 years of age and signed written informed consent
2. Patients undergoing elective major open abdominal surgery
2.1. The Indication for operation may be for benign or malignant disease
2.2. Major Surgery is defined as an operation of anticipated duration more than one hour where all or part of an abdominal organ is to be removed (hepatectomy, pancreatectomy procedure, gastrectomy, oesophagectomy, colectomy (total/partial), nephrectomy, cystectomy, hysterectomy).
3. Screening haemoglobin (Hb) greater than or equal to 9.0 g/dL but below or equal to 12.0 g/dL within four weeks of randomisation
4. Randomisation and administration of study infusion a minimum of 14 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
Current exclusion criteria as of 30/09/2016:
1. Patients undergoing laparoscopic surgery
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 C 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
Previous exclusion criteria from 23/04/2015 to 30/09/2016:
1. Patients undergoing laparoscopic surgery
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 C or patient on non-prophylactic antibiotics
7. Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range
8. Received erythropoietin, i.v. iron therapy or blood transfusion in the previous 12 weeks
9. Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or planned within the next 12 months)
10. Patients with severe asthma or severe allergy (requiring hospitalisation within the last 12 months)
11. Unfit for elective surgery
12. Pregnancy or lactation
13. Inability to fully comprehend and/or perform study procedures in the investigator's opinion
14. 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.
Previous exclusion criteria from 24/01/2014 to 23/04/2015:
1. Patients undergoing laparoscopic surgery
2. Body weight under 50kg
3. Known history of acquired iron overload, or family history of haemochromatosis or t
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method