Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Phase 4Not Yet RecruitingNCT04168346

Helsinki University Central Hospital202 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

202

Conditions

Gastric Cancer Anemia Surgery Iron Deficiency Anemia Surgery--Complications

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

The need for blood transfusion

Number of patients needing transfusions

Time frame: Within 30 days from the day of the operation

Secondary Outcomes

Postoperative complications

Postoperative complications measured using Comprehensive complication index

Time frame: Within 30 days from operation

Patients' quality of life (RAND)

RAND questionnaires