Intravenous Iron for Correction of Anaemia After Colorectal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02999217
• Date of registration: 27/10/2016
• Prospective Registration: No
• Primary sponsor: Kaunas University of Medicine
• Public title: Intravenous Iron for Correction of Anaemia After Colorectal Surgery
• Scientific title: The Impact of Treatment of Anaemia With Intravenous Iron on Haematological Values for Patients After Colorectal Surgery
• Date of first enrolment: October 2016
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02999217
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Lithuania

Contacts

• Name: Jurate Gudaityte, MDPhDAssProf

• Name: Jurate Gudaityte, MDPhDAssProf

• Name: Andrius Macas, MDPhDProf
• Affiliation: Head of the Department of Anaesthesiology, Medical academy, Lithuanian University of Health Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- elective colorectal cancer surgery

- preoperative haemoglobin 90-120 g/l

- preoperative plasma ferritin <100 mkg/l

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Intravenous Drug Usage

Anemia, Iron-Deficiency

Colorectal Neoplasms

Colorectal Surgery

Intervention(s)

Drug: Saline

Drug: Iron isomaltoside

Primary Outcome(s)

Changes in haemoglobin level [Time Frame: 4 weeks after surgery]

Secondary Outcome(s)

Changes of reticulocyte haemoglobin count [Time Frame: 4 weeks after surgery]

Number of participants with perioperative complications [Time Frame: 4 weeks after surgery]

Amount of intravenous fluid therapy [Time Frame: From date of randomization until the day of discharge, up to 2 weeks after surgery]

Changes of mean corpuscular volume [Time Frame: 4 weeks after surgery]

Changes of plasma ferritin [Time Frame: 4 weeks after surgery]

Changes of mean corpuscular haemoglobin concentration [Time Frame: 4 weeks after surgery]

Duration of hospital stay [Time Frame: From the date of randomization until the day of discharge, up to 2 weeks after surgery]

Changes of red blood cell count [Time Frame: 4 weeks after surgery]

Rate of blood transfusion [Time Frame: From date of randomization until the day of discharge from the hospital, up to 2 weeks after surgery]

Changes of reticulocyte count [Time Frame: 4 weeks after surgery]

Secondary ID(s)

BEC-MF-74

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharmacosmos A/S

Orivas, Lithuania