Preoperative i.v. Iron Substitution in Patients With Colon Cancer (PREFECO)

February 28, 2024 updated by: Selja Koskensalo, Helsinki University Central Hospital

Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia

About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb <130, female Hb <120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized preoperative iron substitution for patient with iron deficient anemia

Study Type

Interventional

Enrollment (Estimated)

514

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • HUS
      • Espoo, HUS, Finland, 00029
        • Recruiting
        • Jorvi Hospital
        • Contact:
          • Suvi K Rasilainen, Md, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age> 18 years
  • Dg: Colon ca
  • The planned measure: the colon resection
  • Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)

Exclusion Criteria:

  • hyperreactivity for Ferinject
  • haemochromatosis
  • refusal for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron arm
Half of patients get i.v. iron preoperatively
Drug: Ferric carboxymaltose
Iron-arm treated with Ferric carboxymaltose, non-iron arm without
Other Names:
  • Ferinject (intravenous iron )
No Intervention: non-iron arm
Half of patients are treated without i.v. iron substitution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: 30 days
At study, difference between arms will be evaluated: Complications are analysed using Clavien-Dindo classification https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360123/bin/3TT1.jpg
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for red blood cell transfusion
Time Frame: 30 days
Number of Participants in need for red blood cells transfusion per arm
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Director: Selja K Koskensalo, Md, PhD, Abdominal centre, HUCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 26, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKoskensalo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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