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NCT Number: NCT04168346

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Stomach Diseases Stomach Neoplasms Surgery Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ferric carboxymaltose

Drug

Ferric carboxymaltose iv infusion

Placebos

Drug

NaCl 0.9% infusion

Primary outcomes

  1. The need for blood transfusion

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

    Number of patients needing transfusions

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 30 days from operation

    Postoperative complications measured using Comprehensive complication index

  2. Patients' quality of life (RAND)

    Time frame: One and six months after the surgery

    RAND questionnaires

  3. Patients' quality of life (15D)

    Time frame: One and six months after the surgery

    15D questionnaires

  4. Patients' quality of life (EQ-5D)

    Time frame: One and six months after the surgery

    EQ-5D questionnaires

  5. Patients' quality of life (FRAIL)

    Time frame: One and six months after the surgery

    FRAIL questionnaires

  6. Patients' quality of life (PRISMA-7)

    Time frame: One and six months after the surgery

    PRISMA-7 questionnaires

  7. Patients' quality of life (GSRS)

    Time frame: One and six months after the surgery

    GSRS questionnaires

  8. Patients' quality of life (IDQ)

    Time frame: One and six months after the surgery

    IDQ questionnaires

  9. Patients' haemoglobin and iron parameter levels

    Time frame: At the time of hospital discharge (estimated on average 10 days after surgery)

    Patients' haemoglobin and iron parameter levels

  10. Patients' haemoglobin and iron parameter levels

    Time frame: One month after the surgery

    Patients' haemoglobin and iron parameter levels

  11. Patients' haemoglobin and iron parameter levels

    Time frame: Three months after the surgery

    Patients' haemoglobin and iron parameter levels

  12. Re-admission

    Time frame: 30 days after discharge from hospital

    Patient re-admission rates

  13. 90-day mortality

    Time frame: Within 90 days from operation

    90-day mortality

  14. Overall survival

    Time frame: 1, 3 and 5 years from operation

    Overall survival

  15. Length of hospital stay

    Time frame: Within hospital stay, on average 7 - 14 days

    Length of hospital stay

  16. Use of IV iron after operation

    Time frame: Within 3 months from operation

    Number of doses and median dose of IV iron

Study contacts

Contact information is provided by the study sponsor or research team.

Arto Kokkola, MD

CONTACT

[email protected]

+358-9-4711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: IRONSTOMACH

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Nov 19, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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