A prospective randomized controlled trial evaluating the safety and efficacy of patient blood management program in patients with gynecologic cancer

Asan Medical Center0 个研究点目标入组 334 人开始时间: 待定最近更新: 2023年2月8日

试验速览

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•1) Women aged 20-80 years
•2) Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
•3) Patients with ECOG performance status 0-2
•4) Patients with ASA PS 1-2
•5) Preoperative Hgb = 7 g/dL
•6) Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
•7) In case of showing proper organ function
•WBC = 3,000/mm3
•Platelets = 100,000/mm3
•Creatinine = 2.0 mg/dL
•Bilirubin = 1.5 x institutional upper limit normal
•SGOT, SGPT, and ALP = 3 x institutional upper limit normal
•8) Patient who voluntarily signed the informed consent form

•1) Patient who unable to determine whether or not to consent on their own
•2) Patients with serious underlying diseases or complications
•3) Women who are pregnant or lactating
•4) Patients with concurrent infection
•5) Patients who are allergic to existing iron preparations
•6) Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
•7) Patients who have had or received cancer treatment within 5 years, except for non-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder
•8) Patients with iron overload or iron utilization disorders
•9) Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests

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