Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer (IRONSTOMACH)

Helsinki University Central Hospital (HUCH)

Status and phase: Not yet enrolling; Phase 4

Conditions: Iron Deficiency Anemia; Anemia; Gastric Cancer; Surgery; Surgery--Complications

Treatments: Drug: Ferric carboxymaltose; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04168346

HUS/333/2019

Details and patient eligibility

About

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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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.

Treatment:

Drug: Ferric carboxymaltose

Placebo

Placebo Comparator group

Description:

Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug

Treatment:

Drug: Placebos