2024-519738-21-01Not yet recruitingPhase 4
Ironstomach
Preoperative intravenous iron therapy in patients with gastric cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
TO investigate if preoperative iron infusion decreases the risk of transfusions and complications in after operation for gastric cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- 1 Apr 2020
- Lead sponsor
- HUS-Yhtymae
- Diseases
- Gastric and esophageal cancer
- EU CT number
- 2024-519738-21-01
- EudraCT number
- 2019-001005-25
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 202
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with gastric cancer who are having surgery. It tests whether iron given through a vein before surgery lowers the need for blood transfusions and complications after surgery.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Gastric cancer needing planned (not emergency, not palliative) gastrectomy
- Biomarker or test result
- Hemoglobin not above 155 g/l for women or 167 g/l for men before surgery. Transferrin saturation not above 50%.
Main reasons for not taking part
- Emergency or palliative gastrectomy
- Acute bacterial infection
- Known allergy to ferric carboxymaltose or other iron products
- Iron overload, hemochromatosis or polycytemia vera
- Pregnancy, dialysis for chronic renal failure, or need for direct blood transfusion
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
Who the study is looking for
- Adult patients with gastric cancer
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUS-Yhtymae | Helsinki | Finland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.