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| Name | Class |
|---|---|
| Orivas, Lithuania | UNKNOWN |
| Pharmacosmos A/S | INDUSTRY |
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This 4-week prospective double blind anaemia management study evaluates the effect of high-dose postoperative intravenous iron vs placebo for patients after colorectal cancer surgery. Patients with preoperative levels of haemoglobin 90-120 g/l will be randomly assigned to receive either 1 g of intravenous iron or equal amount of saline postoperatively. Comparison will be based on the levels of haemoglobin, ferritin and other haematological parameters over time and profile of clinical recovery.
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.
The Aim: to assess the effect of treatment of preoperative anaemia with intravenous iron on haematological parameters for patients after elective colorectal surgery.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 1 g of intravenous iron isomaltoside given postoperatively for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l). |
|
| Control | Placebo Comparator | The same amount of intravenous saline for patients with preoperative anaemia (Hb 90-120 g/l and plasma ferritin<100 mkg/l). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in haemoglobin level | Haemoglobin level will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of plasma ferritin | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Changes of red blood cell count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jurate Gudaityte, MDPhDAssProf | Contact | +37069808531 | jurate.gudaityte@kaunoklinikos.lt | |
| Andrius Macas, MDPhDProf | Contact | +37068639123 | andrius.macas@kaunoklinikos.lt |
| Name | Affiliation | Role |
|---|---|---|
| Andrius Macas, MDPhDProf | Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology, Lithuanian University of Health Sciences | Recruiting | Kaunas | LT50009 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15050887 | Background | 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. | |
| 22469713 | Background | 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. |
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De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| Saline | Drug | 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 haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery
| 4 weeks after surgery |
| Changes of mean corpuscular volume | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Changes of mean corpuscular haemoglobin concentration | Other haematological variables will be tested in both groups at day 1, 3 postoperatively, day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Changes of reticulocyte count | It will be tested in both groups at the day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Changes of reticulocyte haemoglobin count | It will be tested in both groups at the day of discharge and 4 weeks after surgery | 4 weeks after surgery |
| Rate of blood transfusion | Total amount of blood transfusion units will be counted 2 weeks after surgery in both groups. | From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery |
| Amount of intravenous fluid therapy | Total amount of intravenous fluids will be counted starting from the date of randomization, separately in the operating room, recovery area and each day postoperatively until 2 weeks after surgery in both groups. | From date of randomization until the day of discharge, up to 2 weeks after surgery |
| Number of participants with perioperative complications | Total number of postoperative complications will be counted in both groups. | 4 weeks after surgery |
| Duration of hospital stay | It will be counted in both groups 2 weeks after surgery in both groups. | From the date of randomization until the day of discharge, up to 2 weeks after surgery |
| 18322945 | Background | 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. |
| 21346250 | Background | 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. |
| 21276532 | Background | 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. |
| 16537556 | Background | 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. |
| 24824650 | Background | 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. |
| 25874460 | Background | 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. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017670 |
| Sodium Compounds |