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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Placebo | Placebo Comparator | Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric carboxymaltose | Drug | Ferric carboxymaltose iv infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The need for blood transfusion | Number of patients needing transfusions | Within 30 days from the day of the operation |
| 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 |
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Inclusion Criteria:
- Patients with gastric cancer who will undergo a gastrectomy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arto Kokkola, MD | Contact | +358-9-4711 | arto.kokkola@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Arto Kokkola, MD | Helsinki University Central Hospital | Study Director |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| Placebos |
| Drug |
NaCl 0.9% infusion |
|
| 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 |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |