Preoperative intravenous iron therapy in patients with gastric cancer

Preoperative intravenous iron therapy in patients with gastric cancer - IRONSTOMACH

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001005-25-FI

Enrollment

202

Registered

2019-08-29

Start date

2019-09-19

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Gastric Cancer

Interventions

Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with gastric cancer undergoing a planned gastrectomy 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 127

Exclusion criteria

Exclusion criteria: Patients under 18 years old Patients not in full understanding Hemoglobin levels > 155 g/l for women and >167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively. Transferrin saturation level >50% Emergency gastrectomy Palliative gastrectomy Acute bacterial infection Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products Clinical evidence of iron overload or disturbances in the utilisation of iron Patients <35 kg Dialysis therapy for chronic renal failure Hemochromatosis Polycytemia vera Pregnancy Patients in need of direct blood transfusion ( Criteria for this are hemoglobin < 80 g/l or < 90 g/l if the patient is symptomatic or has a history of heart disease)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.;Secondary Objective: Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described. ;Primary end point(s): The need for blood transfusion (number of patients needing transfusions per cohort). Timeframe: Starting from the day of the operation (also before surgery) and within 30 days from operation. ;Timepoint(s) of evaluation of this end point: The need for blood transfusion (number of patients needing transfusions per cohort). Timeframe: Starting from the day of the operation (also before surgery) and within 30 days from operation.	—

Measure

Time frame

Main Objective: The main objective is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.;Secondary Objective: Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described. ;Primary end point(s): The need for blood transfusion (number of patients needing transfusions per cohort). Timeframe: Starting from the day of the operation (also before surgery) and within 30 days from operation. ;Timepoint(s) of evaluation of this end point: The need for blood transfusion (number of patients needing transfusions per cohort). Timeframe: Starting from the day of the operation (also before surgery) and within 30 days from operation.

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Secondary

Measure	Time frame
Secondary end point(s): Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described.;Timepoint(s) of evaluation of this end point: Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described.	—

Measure

Time frame

Secondary end point(s): Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described.;Timepoint(s) of evaluation of this end point: Postoperative complications measured using Comprehensive complication index, within 30 days from operation • Patients’ quality of life one and six months after the surgery. • Patients’ haemoglobin and iron parameter levels at the time of hospital discharge, one month after the surgery and three months after the surgery • Patient re-admission rates 30 days after discharge from hospital • 90-days mortality • Overall survival 1, 3 and 5 years from operation • Length of hospital stay • Use of IV iron after operation – number of doses and median dose with IQR described.

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Countries

Finland

Contacts

Public ContactHYKS Instituutti

HYKS Instituutti

HYKSinstituutti@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026