Intravenous iron in colorectal cancer associated anaemia

• Conditions: The medical condition to be investigated is anaemia (low blood count) in pre-operative patients with colorectal cancer.; MedDRA version: 14.0Level: LLTClassification code 10005835Term: Blood transfusionSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2011-002185-21-GB
• Lead Sponsor: Research and Development Nottingham University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1) Pre-operative patients with colorectal adenocarcinoma 2) Aged 18 to 75 years 3) Anaemic at point of diagnosis of colorectal adenocarcinoma (haemoglobin 1g/dL below the local laboratory lower limit of normal reference range) 4) Medically fit for surgery
Are the trial subjects under 18? no
Number of subjects for this age range: 116
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) Pregnant and breast feeding females 2) Previous gastric, small bowel or colorectal surgery (where more than 50% of the stomach or small bowel has been resected) 3) Current chemotherapeutic treatment 4) Known previous anaemia not attributable to colorectal adenocarcinoma (e.g. due to an inflammatory disorder) 5) Features necessitating urgent surgery (e.g. obstructive symptoms) 6) Symptomatic anaemia necessitating urgent blood transfusion (e.g. cardiovascular compromise)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified