Multicenter randomized controlled trial comparing Ferric(III)carboxymaltose infusion with oral iron suppletion in the treatment of perioperative anemia in patients with a colorectal carcinoma.

Phase 4

Completed

• Conditions: Anemia; 10018849; 10017990; 10017998

• Registration Number: NL-OMON50394
• Lead Sponsor: Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 198

Inclusion Criteria

Patients with:
- Colorectal carcinoma
- Laparoscopic or open segment resection or a low anterior resection
- Iron deficiency anemia: Hb <7,5 for women and Hb <-8 mmol/ L for men en
TSAT<20%
- Age 18 years or older
-Written informed consent for study participation

Exclusion Criteria

- Palliative surgery / metastasized disease
- Received blood transfusion within one month before screening
- Serum ferritine * 800 µg/L
- Pregnancy
- Preoperative chemoradiation (Short 5x5gy = no exclusion)
- Contraindication for the use of Ferinject or ferrofumarate
- ASA classification > 3
- Use of erythropoietin stimulating agents within three months before screening
- Chronic kidney disease (GFR < 30ml/min/m)
- Myelodysplastic syndrome
- Elevated liver enzymes
- Hereditary Heamochromatosis
- Thalassemia
- Hemolytic anemia/ chronic hemolysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients that will achieve normalization of HB-level.<br /><br>(Normalization Hb: >7.5 mmol/L for women or >8.0 mmol/L for men. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in morbidity score Comprehensive Complication Index.<br /><br>- Change in baseline in other iron/hematological parameters (i.e. TSAT,<br /><br>ferritin, CRP) at pre-operation, at day 1 and at 1, 4 and 8 weeks post-<br /><br>operative.<br /><br>- Time to achieve normalization of HB to minimum reference value.<br /><br>- Change from baseline in health-related Quality of life.<br /><br>- Change from baseline in fatigue scores.<br /><br>- Amount of blood transfusions needed.<br /><br>- Relation between anemia and Glasgow Prognostic Score (derived from CRP and<br /><br>Albumine).<br /><br>- Relation between CRP and degree of anemia.<br /><br>- Gastro-intestinal intolerance of study drug treatment.<br /><br>- Cost-effectiveness of intravenous iron treatment compared to oral. </p><br>