To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients undergoing surgery, radiation therapy, and chemotherapy, and to establish a patient blood management program and introduce it as a standard treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
334
ferric carboxymaltose 1000mg, fixed dose for intervention group
pack RBC transfusion
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, South Korea
transfusion rate
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
Time frame: within 3 weeks after surgery
hemoglobin differences
Comparison of hemoglobin differences between the groups
Time frame: within 3 weeks after surgery
Frequency of anemia
Frequency of anemia and blood transfusion before adjuvant therapy between the groups
Time frame: within 3 weeks after surgery
Frequency and delay period of treatment
Frequency and delay period of treatment delay due to anemia before adjuvant therapy between the groups
Time frame: within 3 weeks after surgery
The costs that patients actually pay for treatment (Cost-effectiveness)
Investigate, evaluate, and compare the costs that patients actually pay for treatment between the two groups.
Time frame: within 3 weeks after surgery
Quality of life of patients EORTC QLQ-C30
used to collect information on patients' quality of life and compare the scores of the two groups. Scores are given from 1 to 4 for most questions, and the lower the score, the better the patient's quality of life is evaluated. The average of the total scores is used to compare the two groups.
Time frame: within 3 weeks after surgery
Adverse events
ADR (adverse drug reaction) is investigated between the two groups, and the rate of adverse reactions and the rate of moderate adverse reactions in each group are compared.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: within 3 weeks after surgery
Quality of life of patients HINT-8
HINT-8 used to collect information on patients' quality of life and compare the scores of the two groups. Each answer is given to 8 questions, and each answer is scored and assigned from 1 to 4 points, and the averages of the two groups are also compared.
Time frame: within 3 weeks after surgery