Clinical Trials Directory

Trials / Unknown

UnknownNCT05221957

Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Zealand University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included

Conditions

Interventions

TypeNameDescription
DRUGIron(III)isomaltosideIndividual weight and hemoglobin dependent dosage

Timeline

Start date
2022-03-01
Primary completion
2023-12-01
Completion
2023-12-01
First posted
2022-02-03
Last updated
2022-02-03

Source: ClinicalTrials.gov record NCT05221957. Inclusion in this directory is not an endorsement.