Intravenous Iron for Correction of Anaemia After Colorectal Surgery
NCT ID: NCT02999217
Last Updated: 2016-12-21
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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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-10-31
2018-10-31
Brief Summary
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The primary end point is that iron isomaltoside given postoperatively is superior to placebo in terms of increase and stability of levels of haemoglobin and other haematological parameters.
Detailed Description
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Primary Hypothesis: postoperative treatment with intravenous iron increases the levels of haemoglobin, ferritin, red cell count and is superior compared to placebo.
Secondary effects: treatment with intravenous iron vs placebo provides reduction of blood transfusions, postoperative complications and hospital stay.
The Objectives:
1. To estimate the rate of preoperative anaemia in patients of elective colorectal surgery.
2. To assess the dynamic changes of total blood count values in colorectal surgery patients treated with postoperative intravenous iron.
3. To compare the changes in total blood count values over time in colorectal surgery patients treated with intravenous iron versus colorectal surgery patients of the control group.
Methods:
The prospective, double-blinded study includes American Society of Anaesthesiology (ASA) I-III patients, aged 18-75 years, admitted for elective colorectal surgery. Preoperatively, patients with levels of haemoglobin 90-120 g/l will be identified and their serum ferritin will be tested. In cases of ferritin\<100 mkg/l, patients will be blindly randomized into one of the two groups: treatment group (group T) is given 1000 mg of intravenous iron (iron isomaltoside, Orivas, Pharmacosmos) in the postoperative recovery ward and control group (group C) which is given the same volume of intravenous saline (placebo).
Patients in both groups will be provided with general anaesthesia (fentanyl, propofol, atracurium, inhaled sevoflurane for maintenance) and after tracheal extubation will be transferred to the recovery ward.
Patient blood tests: total blood count, haemoglobin, haematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), plasma ferritin) will be assessed in both groups 1 day preoperatively, day 1 and 3 postoperatively, the day of discharge and 4 weeks after discharge from the department of surgery. The level of reticulocyte and reticulocyte haemoglobin concentration will be determined on the day of discharge and 4 weeks after discharge.
According to the study protocol, groups will also be compared in terms of clinical recovery, requirements of intravenous fluids and blood transfusion and duration of hospital stay.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment
1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).
Iron isomaltoside
Intravenous injection 1 g given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
Control
The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin\<100 mkg/l).
Saline
Intravenous injection given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
Interventions
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Iron isomaltoside
Intravenous injection 1 g given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
Saline
Intravenous injection given postoperatively in the recovery ward.
Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* preoperative haemoglobin 90-120 g/l
* preoperative plasma ferritin \<100 mkg/l
Exclusion Criteria
* body mass \<50kg
* history of overdosage of iron products
* family history of haemochromatosis, thalassaemia,
* non-iron deficiency anaemia (Vit. B12, folic acid defficiency, haemoglobinopathies)
* under treatment with erythropoietin, intravenous iron or blood transfusion in the last 12 weeks
* allergy to iron carboxymaltose or its supplements
* body temperature \> 37.5 °C or under antibiotic use
* chronic liver diseases or/and increased levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times over normal upper limit
* patients ill with grave bronchial asthma
* patients with manifestation of allergy
18 Years
75 Years
ALL
No
Sponsors
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Orivas, Lithuania
UNKNOWN
Pharmacosmos A/S
INDUSTRY
Kaunas University of Medicine
OTHER
Responsible Party
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Principal Investigators
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Andrius Macas, MDPhDProf
Role: STUDY_CHAIR
Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences
Locations
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Department of Anaesthesiology, Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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Jurate Gudaityte, MDPhDAssProf
Role: primary
Andrius Macas, MDPhDProf
Role: backup
References
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Shander A, Knight K, Thurer R, Adamson J, Spence R. Prevalence and outcomes of anemia in surgery: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:58S-69S. doi: 10.1016/j.amjmed.2003.12.013.
Edna TH, Karlsen V, Jullumstro E, Lydersen S. Prevalence of anaemia at diagnosis of colorectal cancer: assessment of associated risk factors. Hepatogastroenterology. 2012 May;59(115):713-6. doi: 10.5754/hge11479.
Ward DG, Roberts K, Brookes MJ, Joy H, Martin A, Ismail T, Spychal R, Iqbal T, Tselepis C. Increased hepcidin expression in colorectal carcinogenesis. World J Gastroenterol. 2008 Mar 7;14(9):1339-45. doi: 10.3748/wjg.14.1339.
Ganz T. Hepcidin and iron regulation, 10 years later. Blood. 2011 Apr 28;117(17):4425-33. doi: 10.1182/blood-2011-01-258467. Epub 2011 Feb 23.
Leichtle SW, Mouawad NJ, Lampman R, Singal B, Cleary RK. Does preoperative anemia adversely affect colon and rectal surgery outcomes? J Am Coll Surg. 2011 Feb;212(2):187-94. doi: 10.1016/j.jamcollsurg.2010.09.013.
Cladellas M, Bruguera J, Comin J, Vila J, de Jaime E, Marti J, Gomez M. Is pre-operative anaemia a risk marker for in-hospital mortality and morbidity after valve replacement? Eur Heart J. 2006 May;27(9):1093-9. doi: 10.1093/eurheartj/ehi830. Epub 2006 Mar 14.
Hogan M, Klein AA, Richards T. The impact of anaemia and intravenous iron replacement therapy on outcomes in cardiac surgery. Eur J Cardiothorac Surg. 2015 Feb;47(2):218-26. doi: 10.1093/ejcts/ezu200. Epub 2014 May 13.
Elhenawy AM, Meyer SR, Bagshaw SM, MacArthur RG, Carroll LJ. Role of preoperative intravenous iron therapy to correct anemia before major surgery: study protocol for systematic review and meta-analysis. Syst Rev. 2015 Mar 15;4:29. doi: 10.1186/s13643-015-0016-4.
Other Identifiers
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BEC-MF-74
Identifier Type: -
Identifier Source: org_study_id