Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Conditions
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Gastric Cancer, Anemia, Surgery, Iron Deficiency Anemia, Surgery--Complications

Intervention / Treatment
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* Drug: Ferric carboxymaltose
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Drug: Ferric carboxymaltose<br>* Ferric carboxymaltose iv infusion<br>|
| Placebo Comparator: Placebo<br>Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug | Drug: Placebos<br>* NaCl 0.9% infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The need for blood transfusion | Number of patients needing transfusions | Within 30 days from the day of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications measured using Comprehensive complication index | Within 30 days from operation | 
| Patients' quality of life (RAND) | RAND questionnaires | One and six months after the surgery | 
| Patients' quality of life (15D) | 15D questionnaires | One and six months after the surgery | 
| Patients' quality of life (EQ-5D) | EQ-5D questionnaires | One and six months after the surgery | 
| Patients' quality of life (FRAIL) | FRAIL questionnaires | One and six months after the surgery | 
| Patients' quality of life (PRISMA-7) | PRISMA-7 questionnaires | One and six months after the surgery | 
| Patients' quality of life (GSRS) | GSRS questionnaires | One and six months after the surgery | 
| Patients' quality of life (IDQ) | IDQ questionnaires | One and six months after the surgery | 
| Patients' haemoglobin and iron parameter levels | Patients' haemoglobin and iron parameter levels | At the time of hospital discharge (estimated on average 10 days after surgery) | 
| Patients' haemoglobin and iron parameter levels | Patients' haemoglobin and iron parameter levels | One month after the surgery | 
| Patients' haemoglobin and iron parameter levels | Patients' haemoglobin and iron parameter levels | Three months after the surgery | 
| Re-admission | Patient re-admission rates | 30 days after discharge from hospital | 
| 90-day mortality | 90-day mortality | Within 90 days from operation | 
| Overall survival | Overall survival | 1, 3 and 5 years from operation | 
| Length of hospital stay | Length of hospital stay | Within hospital stay, on average 7 - 14 days | 
| Use of IV iron after operation | Number of doses and median dose of IV iron | Within 3 months from operation |