Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
- Conditions
- AnemiaSurgeryGastric CancerIron Deficiency AnemiaSurgery--Complications
- Interventions
- Drug: Placebos
- Registration Number
- NCT04168346
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 202
- Patients with gastric cancer who will undergo a gastrectomy
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug Intervention Ferric carboxymaltose 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.
- Primary Outcome Measures
Name Time Method The need for blood transfusion Within 30 days from the day of the operation Number of patients needing transfusions
- Secondary Outcome Measures
Name Time Method Postoperative complications Within 30 days from operation Postoperative complications measured using Comprehensive complication index
90-day mortality Within 90 days from operation 90-day mortality
Overall survival 1, 3 and 5 years from operation Overall survival
Length of hospital stay Within hospital stay, on average 7 - 14 days Length of hospital stay
Use of IV iron after operation Within 3 months from operation Number of doses and median dose of IV iron
Patients' quality of life (15D) One and six months after the surgery 15D questionnaires
Patients' quality of life (EQ-5D) One and six months after the surgery EQ-5D questionnaires
Patients' quality of life (FRAIL) One and six months after the surgery FRAIL questionnaires
Patients' quality of life (PRISMA-7) One and six months after the surgery PRISMA-7 questionnaires
Re-admission 30 days after discharge from hospital Patient re-admission rates
Patients' quality of life (RAND) One and six months after the surgery RAND questionnaires
Patients' haemoglobin and iron parameter levels Three months after the surgery Patients' haemoglobin and iron parameter levels
Patients' quality of life (GSRS) One and six months after the surgery GSRS questionnaires
Patients' quality of life (IDQ) One and six months after the surgery IDQ questionnaires