The Dose-Response Relationship of Intraoperative Iron Isomaltoside 1000 (Monofer®) on Hemoglobin in Patients undergoing Gastrectomy
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0004900
- Lead Sponsor
- Pharmbio Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
?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
? 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method dose response relationship in hemoglobin response
- Secondary Outcome Measures
Name Time Method scale of quality of life