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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001005-13-ES

Enrollment

Registered

2015-06-01

Start date

2015-07-16

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The medical condition being studied is anemia after a neoplastic colorectal surgery. MedDRA version: 18.0 Level: LLT Classification code 10071378 Term: Ferropenic anemia System Organ Class: 100000004851

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients older than 18 years who undergo neoplastic surgery of colorectal cancer. Patients with a hemoglobin =65 years) yes F.1.3.1 Number of subjects for this age range 48

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of two iron regimens for the treatment of postoperative anemia in patients undergoing colorectal neoplasia surgery.;Secondary Objective: Compare the percentage of patients with Hb levels> 13 g / dL, with Hb between 11 and 12 g / dL and <11g / dL at day 30 postsurgery with two different regimens of iron therapy. Describe the number of patients with mild, moderate or severe postoperative anemia on day 30. Compare iron metabolism at day 30 (iron, ferritin, transferrin, % transferrin saturation). Compare the total dose of intravenous and oral iron administered at day 30 postsurgery. Compare resource utilization: hospital readmissions, number of days hospitalized at day 30 postsurgery. Compare transfusion rate postoperatively. Compare postoperative complications. Compare adverse effects associated with iron therapy. Describe compliance with ambulatory oral iron therapy. Compare the quality of life with both treatment regimens at day 30 postsurgery.;Primary end point(s): Change in hemoglobin levels from postoperative day 1 to day 30;Timepoint(s) of evaluation of this end point: Day 4 postsurgery Day 30 postsurgery	—

Measure

Time frame

Main Objective: To compare the efficacy of two iron regimens for the treatment of postoperative anemia in patients undergoing colorectal neoplasia surgery.;Secondary Objective: Compare the percentage of patients with Hb levels> 13 g / dL, with Hb between 11 and 12 g / dL and <11g / dL at day 30 postsurgery with two different regimens of iron therapy. Describe the number of patients with mild, moderate or severe postoperative anemia on day 30. Compare iron metabolism at day 30 (iron, ferritin, transferrin, % transferrin saturation). Compare the total dose of intravenous and oral iron administered at day 30 postsurgery. Compare resource utilization: hospital readmissions, number of days hospitalized at day 30 postsurgery. Compare transfusion rate postoperatively. Compare postoperative complications. Compare adverse effects associated with iron therapy. Describe compliance with ambulatory oral iron therapy. Compare the quality of life with both treatment regimens at day 30 postsurgery.;Primary end point(s): Change in hemoglobin levels from postoperative day 1 to day 30;Timepoint(s) of evaluation of this end point: Day 4 postsurgery Day 30 postsurgery

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Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients that reach Hb levels > 13g/dL Percentage of patients discontinuing treatment with oral iron. Changes in values of iron metabolism parameters at 30 days (iron, ferritin, transferrin,% transferrin saturation). Total dose of iron received within 30 days after surgery. Number of transfusions postoperatively. Number of medical and surgery complications. Adverse effects reported by the patient. Use of healthcare resources in the postoperative period: Number of readmissions, number of days hospitalized at 30 days. Changes in scores of quality of life questionnaire QLQ-C30.;Timepoint(s) of evaluation of this end point: Day 4 postsurgery Day 30 postsurgery	—

Measure

Time frame

Secondary end point(s): Percentage of patients that reach Hb levels > 13g/dL Percentage of patients discontinuing treatment with oral iron. Changes in values of iron metabolism parameters at 30 days (iron, ferritin, transferrin,% transferrin saturation). Total dose of iron received within 30 days after surgery. Number of transfusions postoperatively. Number of medical and surgery complications. Adverse effects reported by the patient. Use of healthcare resources in the postoperative period: Number of readmissions, number of days hospitalized at 30 days. Changes in scores of quality of life questionnaire QLQ-C30.;Timepoint(s) of evaluation of this end point: Day 4 postsurgery Day 30 postsurgery

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Countries

Spain

Contacts

Public ContactOficina de Recerca

Hospital Universitari Parc Taulí

afarre@tauli.cat34937458451

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 22, 2026