The Dose-Response Relationship of Intraoperative Iron Isomaltoside 1000 (Monofer®) on Hemoglobin in Patients undergoing Gastrectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004900

Enrollment

Registered

2020-04-08

Start date

2020-07-22

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : control group(n=36)

normal saline 100ml low dose(n=36)

Iron isomaltoside 1000 500 mg/100 ml normal saline high dose(n=18)

Iron isomaltoside 1000 1000 mg/100 ml normal saline

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ?Patients undergoing stomach resection using general anesthesia ?Adults between 20-60 years old ? Patients weighted over 50 kg ? Patients with iron-deficient anemia (IDA), 10 = Hb < 13 g/dl for male, 9 = Hb < 12 g/dl for female ? American Society of Anesthesiologists(ASA) 1-2 class ? Given with formal informed consent

Exclusion criteria

Exclusion criteria: ? Patients with anemia, Hb < 10 g/dl for male, Hb < 9 g/dl for female ? Patients with decreased eGFR(= 60 mL/min, estimated glomerular filtration rate calculated by CKD-EPI equation) ? Chronic liver disease or increase in liver enzymes (alanine and aspartate aminotransferase) more than 3 times the upper limit of the normal range ? Transferrin saturation = 45% ? Patients with sign or symptoms of active severe infection or inflammation ? Patients with active or chronic hepatitis ? Patients with history of immunologic or inflammtory diseses including Allergy Rheumatoid arthritis Asthma Systemic lupus erythematosus Crohn's disease ? Patients with liver cirrhosis, hemochromatosis, or hemosiderosis ? Receipt of transfusion, erythropoietin stimulating agent, or more than 500 mg of intraveonous iron within 4 weeks prior to screening ? Patients of pregnancy or lactation ? Participation in any other interventional study within 1 month prior to screening ? Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion

Design outcomes

Secondary

Measure	Time frame
scale of quality of life	—

Primary

Measure	Time frame
dose response relationship in hemoglobin response	—

Countries

Korea, Republic of

Contacts

Public ContactJi-Yeon Bang

Asan Medical Center

maflada@naver.com+82-2-3010-3868

Outcome results