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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04653181
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Selja Koskensalo, Helsinki University Central Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Ferric carboxymaltose Not Applicable

Detailed Description:
Randomized preoperative iron substitution for patient with iron deficient anemia
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative i.v. Iron Substitution in Patients With Colon Carcinoma and Iron-deficiency Anemia
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery Iron

Arms and Interventions
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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 Name: Ferinject (intravenous iron )
No Intervention: non-iron arm
Half of patients are treated without i.v. iron substitution


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Need for red blood cell transfusion [ Time Frame: 30 days ]
    Number of Participants in need for red blood cells transfusion per arm


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04653181


Contacts
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Contact: Suvi K Rasilainen, Md, PhD +35894711 ext +358504271748 suvi.rasilainen@hus.fi

Locations
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Finland
Jorvi Hospital Recruiting
Espoo, HUS, Finland, 00029
Contact: Suvi K Rasilainen, Md, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Selja K Koskensalo, Md, PhD Abdominal centre, HUCH
More Information
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Publications:

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Responsible Party: Selja Koskensalo, Consultant, abdominal surgeon,Md, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04653181    
Other Study ID Numbers: SKoskensalo
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selja Koskensalo, Helsinki University Central Hospital:
postoperative complications
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases