Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Gastric Cancer Clinical Trial

— IRONSTOMACH  

Official title:

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04168346
• Other study ID #: HUS/333/2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2019
• Est. completion date: November 2026

Study information

• Verified date: November 2019
• Source: Helsinki University Central Hospital
• Contact: Arto Kokkola, MD
• Phone: +358-9-4711
• Email: arto.kokkola[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 202
• Est. completion date: November 2026
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Gastric Cancer
• Iron Deficiency Anemia
• Stomach Neoplasms
• Surgery
• Surgery--Complications

Intervention

Drug:
• Ferric carboxymaltose
Ferric carboxymaltose iv infusion
• Placebos
NaCl 0.9% infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for blood transfusion	Number of patients needing transfusions	Within 30 days from the day of the operation
Secondary	Postoperative complications	Postoperative complications measured using Comprehensive complication index	Within 30 days from operation
Secondary	Patients' quality of life (RAND)	RAND questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (15D)	15D questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (EQ-5D)	EQ-5D questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (FRAIL)	FRAIL questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (PRISMA-7)	PRISMA-7 questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (GSRS)	GSRS questionnaires	One and six months after the surgery
Secondary	Patients' quality of life (IDQ)	IDQ questionnaires	One and six months after the surgery
Secondary	Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	At the time of hospital discharge (estimated on average 10 days after surgery)
Secondary	Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	One month after the surgery
Secondary	Patients' haemoglobin and iron parameter levels	Patients' haemoglobin and iron parameter levels	Three months after the surgery
Secondary	Re-admission	Patient re-admission rates	30 days after discharge from hospital
Secondary	90-day mortality	90-day mortality	Within 90 days from operation
Secondary	Overall survival	Overall survival	1, 3 and 5 years from operation
Secondary	Length of hospital stay	Length of hospital stay	Within hospital stay, on average 7 - 14 days
Secondary	Use of IV iron after operation	Number of doses and median dose of IV iron	Within 3 months from operation