Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Nov 16, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether giving intravenous iron before surgery can help patients with gastric cancer avoid needing blood transfusions during or after their surgery. The study focuses on patients who will have a gastrectomy, which is a surgery to remove part or all of the stomach. Researchers believe that providing iron through an IV may improve patients' iron levels and reduce the chance of needing extra blood during their treatment.

To participate in this trial, patients must be adults diagnosed with gastric cancer and scheduled for a gastrectomy. However, there are some important criteria that would exclude someone from joining, such as being under 18 years old or having very high hemoglobin levels. If eligible, participants can expect to receive iron treatment before their surgery and be monitored closely throughout the process. This study is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

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)