Intravenous Iron for Correction of Anaemia After Colorectal Surgery

NCT02999217 | Unknown Phase 4 DMC

• 1 other identifier: BEC-MF-74
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia, Iron-Deficiency; Intravenous Drug Usage; Colorectal Neoplasms; Colorectal Surgery

Keywords

iron isomaltoside; plasma ferritin; haemoglobin; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Changes of plasma ferritin

  4 weeks after surgery

• Changes of red blood cell count

  4 weeks after surgery

• Changes of mean corpuscular volume

  4 weeks after surgery

• Changes of mean corpuscular haemoglobin concentration

  4 weeks after surgery

• Changes of reticulocyte count

  4 weeks after surgery

Study Arms (2)

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).

Drug: Iron isomaltoside

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).

Drug: Saline

Interventions

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.

Also known as: Monofer

Treatment

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.

Also known as: Sodium chloride

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective colorectal cancer surgery
• preoperative haemoglobin 90-120 g/l
• preoperative plasma ferritin \<100 mkg/l

You may not qualify if:

• laparoscopic colorectal surgery
• 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

Sponsors & Collaborators

• Kaunas University of Medicine: lead
• Orivas, Lithuania: collaborator
• Pharmacosmos A/S: collaborator

Study Sites (1)

Department of Anaesthesiology, Lithuanian University of Health Sciences

Kaunas, LT50009, Lithuania

RECRUITING

Related Publications (8)

• 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.

  PMID: 15050887 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.

  PMID: 22469713 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.

  PMID: 18322945 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.

  PMID: 21346250 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.

  PMID: 21276532 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.

  PMID: 16537556 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.

  PMID: 24824650 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.

  PMID: 25874460 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Colorectal Neoplasms

Interventions

iron isomaltoside 1000; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andrius Macas, MDPhDProf

  Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences

  STUDY CHAIR

Central Study Contacts

Jurate Gudaityte, MDPhDAssProf

CONTACT

+37069808531; jurate.gudaityte@kaunoklinikos.lt

Andrius Macas, MDPhDProf

CONTACT

+37068639123; andrius.macas@kaunoklinikos.lt

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: December 21, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

LI (1)