Clinical trial · Interventional
Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
NCT04168346CI-TRIAL-00041731IRONSTOMACHnot yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this investigator initiated study 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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Iron Deficiency Anemia | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferric carboxymaltose | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- IV-iron substitution: The intravenous iron formulation used in the study is ferric carboxymaltose and it will be administered two to four weeks before the surgery, aiming at four weeks. The dose of intravenous iron will be calculated according to the weight and haemoglobin level of the patients, however so that all the patients receive minimum 1000mg iv iron and the maximum dose is 20 mg/kg per day.
- interventionNames
- Drug: Ferric carboxymaltose
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
- interventionNames
- Drug: Placebos
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Patients with gastric cancer who will undergo a gastrectomy 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 * Polycythemia 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)
References
Publications (0)
Data not yet available
No reference posted for this study.