ISRCTN67322816已完成未知
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
niversity College London (UK)0 个研究点目标入组 487 人开始时间: 2012年10月9日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 487
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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