EUCTR2018-004213-41-BE
Active, not recruiting
Phase 1
Effect of intravenous replenishment of iron in the preoperative management of anemia in patients with colon cancer: RIPAC-trial - RIPAC-trial
niversity Hospital Ghent0 sites60 target enrollmentMay 6, 2019
DrugsInjectafer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospital Ghent
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a M0\-stage colon carcinoma who are scheduled for segmental colonic resection
- •Patients with a Hb higher than 6\.5 g/dl or 7\.5 g/dl in patients with cardiac disease at moment of diagnosis
- •Patients with a proven iron deficiency anemia defined by a Hb lower than 13g/dl in men and 12g/dl in women with a transferrin saturation lower than 20%.
- •Obtained informed consent
- •\=18 years; female or male
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 9
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •The period between diagnosis and surgery is less than two weeks
- •Hemochromatosis, iron overload, defined as TSAT \> 45%
- •Known hypersensitivity to Injectafer®
- •Metastatic colon disease
- •Patients not suitable for surgery due to age or comorbidities
- •Pregnancy, lactation or woman of childbearing potential who don’t use an effective method of contraception
- •Administration of IV iron/oral iron/ESA in the past three months before inclusion
- •Administration of blood transfusion in the past month before inclusion
- •Chronic kidney disease with a eGFR \< 30 ml/min
- •Hematological disorders as a cause of anemia (myelodysplastic syndrome, leukemia, chronic hemolysis)
Outcomes
Primary Outcomes
Not specified
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