NCT02057471

Brief Summary

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT). It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

February 3, 2014

Last Update Submit

February 5, 2014

Conditions

Colorectal NeoplasmAnemia

Keywords

AdenocarcinomaAnemiaBlood TransfusionColorectal surgeryPreoperative carePerioperative carePostoperative careIronHematinicsHepcidinQuality of lifePostoperative complications

Outcome Measures

Primary Outcomes (2)

  • Number of patients transfused allogenic red blood cells

    To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase

    Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks

  • Hemoglobin levels

    To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

    Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks

Secondary Outcomes (5)

  • Hepcidin levels

    Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks

  • Erythropoietin levels

    Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks

  • Transferrin saturation levels

    Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks

  • Ferritin levels

    Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks

  • C Reactive Protein levels

    Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks

Other Outcomes (1)

  • Number of adverse events associated with intravenous iron infusion

    Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks

Study Arms (1)

Intravenous Ferric Carboxymaltose

EXPERIMENTAL

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

Drug: Intravenous ferric carboxymaltose

Interventions

Intravenous ferric carboxymaltoseDRUG

1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Also known as: FERINJECT
Intravenous Ferric Carboxymaltose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Diagnosed with colonic or rectal adenocarcinoma
  • Defined date of operation at least 14 days from recruitment to study
  • Confirmed anemia
  • Females of child bearing age must agree to use a medically accepted form of contraceptive

You may not qualify if:

  • Patient's who are unable to consent
  • Recognized allergy or intolerance of the study drug or excipients
  • Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Colorectal NeoplasmsAnemiaAdenocarcinomaPostoperative Complications

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Austin G Acheson, MD FRCS

    Nottingham University Hospitals NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 7, 2014

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

GB(1)