Randomized open label clinical trial to compare two regimens of intravenous iron therapy after colorectal cancer surgery.

• Conditions: The medical condition being studied is anemia after a neoplastic colorectal surgery.; MedDRA version: 18.0Level: LLTClassification code 10071378Term: Ferropenic anemiaSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-001005-13-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients older than 18 years who undergo neoplastic surgery of colorectal cancer.
Patients with a hemoglobin <= 11 g / dL on day 1 after neoplastic surgery.
Patients that give their informed consent to participate in the study.
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 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

Patients who on day 1 after colonic neoplastic surgery have Hb levels > 11g / dL.
Patients who have had adverse reactions to intravenous iron or a contraindication to intravenous iron according to the SmPC.
Patients with ASA anesthetic risk grade 4.
Patients presenting postoperative complications Claviens grade 4.
Pregnant or lactating women.
Any circumstance that in the opinion of the responsible physician may cause the patient any harm or may interfere with the study assessments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified