Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 202
- Primary Endpoint
- The need for blood transfusion
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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 (Drug)
Placebo
Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
Intervention: Placebos (Drug)
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)
Investigators
Ville Sallinen
MD, Phd, Adj. Professor
Helsinki University Central Hospital