Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

NCT04168346 | Not Yet Recruiting Phase 4

• 1 other identifier: HUS/333/2019
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The need for blood transfusion

  Number of patients needing transfusions

  Within 30 days from the day of the operation

Secondary Outcomes (16)

• Postoperative complications

  Within 30 days from operation

• Patients' quality of life (RAND)

  One and six months after the surgery

• Patients' quality of life (15D)

  One and six months after the surgery

• Patients' quality of life (EQ-5D)

  One and six months after the surgery

• Patients' quality of life (FRAIL)

  One and six months after the surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Ferric carboxymaltose

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Ferric carboxymaltose DRUG

Ferric carboxymaltose iv infusion

Intervention

Placebos DRUG

NaCl 0.9% infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with gastric cancer who will undergo a gastrectomy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms; Anemia; Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Arto Kokkola, MD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Arto Kokkola, MD

CONTACT

+358-9-4711; arto.kokkola@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd, Adj. Professor

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 19, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share