Anemia, Gastric Cancer, Iron Deficiency Anemia, Surgery, Surgery--Complications
Conditions
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.
Interventions
DRUGFerric carboxymaltose
Ferric carboxymaltose iv infusion
DRUGPlacebos
NaCl 0.9% infusion
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The need for blood transfusion | Within 30 days from the day of the operation | Number of patients needing transfusions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patients' quality of life (GSRS) | One and six months after the surgery | GSRS questionnaires |
| Postoperative complications | Within 30 days from operation | Postoperative complications measured using Comprehensive complication index |
| Patients' quality of life (RAND) | One and six months after the surgery | RAND questionnaires |
| 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' haemoglobin and iron parameter levels | At the time of hospital discharge (estimated on average 10 days after surgery) | Patients' haemoglobin and iron parameter levels |
| Re-admission | 30 days after discharge from hospital | Patient re-admission rates |
| 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 (IDQ) | One and six months after the surgery | IDQ questionnaires |
Contacts
Primary ContactArto Kokkola, MD
Outcome results
None listed