Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

NCT ID: NCT04168346

Last Updated: 2019-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2026-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Ferric carboxymaltose iv infusion

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

NaCl 0.9% infusion

Interventions

Ferric carboxymaltose

Ferric carboxymaltose iv infusion

Intervention Type: DRUG

Placebos

NaCl 0.9% infusion

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ville Sallinen

MD, Phd, Adj. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arto Kokkola, MD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Central Contacts

Arto Kokkola, MD

Role: CONTACT

arto.kokkola@hus.fi

+358-9-4711

Other Identifiers

HUS/333/2019

Identifier Type: -

Identifier Source: org_study_id