Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
Overview
- Phase
- Phase 4
- Intervention
- Ferric carboxymaltose
- Conditions
- Gastric Cancer
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 202
- Primary Endpoint
- The need for blood transfusion
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Ville Sallinen
MD, Phd, Adj. Professor
Helsinki University Central Hospital
Eligibility Criteria
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
Arms & Interventions
Intervention
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.
Intervention: Ferric carboxymaltose
Placebo
Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
Intervention: Placebos
Outcomes
Primary Outcomes
The need for blood transfusion
Time Frame: Within 30 days from the day of the operation
Number of patients needing transfusions
Secondary Outcomes
- Patients' quality of life (15D)(One and six months after the surgery)
- Patients' quality of life (EQ-5D)(One and six months after the surgery)
- Patients' quality of life (FRAIL)(One and six months after the surgery)
- Patients' quality of life (PRISMA-7)(One and six months after the surgery)
- Re-admission(30 days after discharge from hospital)
- Patients' quality of life (RAND)(One and six months after the surgery)
- Postoperative complications(Within 30 days from operation)
- 90-day mortality(Within 90 days from operation)
- Overall survival(1, 3 and 5 years from operation)
- Length of hospital stay(Within hospital stay, on average 7 - 14 days)
- Use of IV iron after operation(Within 3 months from operation)
- Patients' haemoglobin and iron parameter levels(Three months after the surgery)
- Patients' quality of life (GSRS)(One and six months after the surgery)
- Patients' quality of life (IDQ)(One and six months after the surgery)