Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric carboxymaltose, Placebos.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Anemia, Surgery, Iron Deficiency Anemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Ferric carboxymaltose
Ferric carboxymaltose iv infusion - Drug Placebos
NaCl 0.9% infusion
Primary outcome measures
- The need for blood transfusion [Time frame: Within 30 days from the day of the operation]
Secondary outcome measures (12)
- Postoperative complications [Time frame: Within 30 days from operation]
- Patients' quality of life (RAND) [Time frame: One and six months after the surgery]
- Patients' quality of life (15D) [Time frame: One and six months after the surgery]
- Patients' quality of life (EQ-5D) [Time frame: One and six months after the surgery]
- Patients' quality of life (FRAIL) [Time frame: One and six months after the surgery]
- Patients' quality of life (PRISMA-7) [Time frame: One and six months after the surgery]
- Patients' quality of life (GSRS) [Time frame: One and six months after the surgery]
- Patients' quality of life (IDQ) [Time frame: One and six months after the surgery]
- Patients' haemoglobin and iron parameter levels [Time frame: At the time of hospital discharge (estimated on average 10 days after surgery)]
- Patients' haemoglobin and iron parameter levels [Time frame: One month after the surgery]
- Patients' haemoglobin and iron parameter levels [Time frame: Three months after the surgery]
- Re-admission [Time frame: 30 days after discharge from hospital]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04168346 · HUS/333/2019