NCT05669872尚未招募不适用
A Prospective Randomized Controlled Trial Evaluating the Safety and Efficacy of Patient Blood Management Program in Patients With Gynecologic Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- transfusion rate
研究概览
简要总结
To demonstrate the safety and effectiveness of a patient blood management program in gynecological cancer patients
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-80 years
- •Untreated, histologically diagnosed cervical cancer, endometrial cancer, and ovarian cancer (including cases diagnosed by imaging without biopsy in the case of ovarian cancer)
- •Patients with ECOG performance status 0-2
- •Patients with ASA PS 1-2
- •Preoperative Hgb ≥ 7 g/dL
- •Patients who are scheduled for preoperative iron panel test (serum ferritin, iron, TIBC)
- •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
- •Patient who voluntarily signed the informed consent form
排除标准
- •Patient who unable to determine whether or not to consent on their own
- •Patients with serious underlying diseases or complications
- •Women who are pregnant or lactating
- •Patients with concurrent infection
- •Patients who are allergic to existing iron preparations
- •Patients who underwent neoadjuvant chemotherapy or preoperative radiation therapy
- •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
- •Patients with iron overload or iron utilization disorders
- •Patients with serum ferritin > 800ng/mL or TSAT > 50% on Iron panel tests
研究组 & 干预措施
patient blood management group
Experimental
- before surgery (within 2-6 weeks before surgery)
- 7 ≤ Hb < 12 g/dL : ferric carboxymaltose 1000mg
- during surgery
- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist
- after surgery (POD #1)
- 7 ≤ Hb < 12 g/dL : ferric carboxymaltose 1000mg
- Hb <7 g/dL : pRBC 2 packs transfusion
干预措施: Ferric Carboxymaltose 50Mg/Ml Inj 20Ml (Drug)
conventional management group
Active Comparator
- before surgery (within 2-6 weeks before surgery)
- 8 ≤ Hb < 10 g/dL: pRBC 1 pack transfusion
- Hb < 8 g/dL: pRBC 2 packs transfusion * Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements)
- during surgery
- In case of hemodynamically unstable, transfusion according to the judgment of the operating surgeon and anesthesiologist
- after surgery (POD #1)
- 8 ≤ Hb < 10 g/dL: pRBC 1 pack transfusion
- Hb < 8 g/dL: pRBC 2 packs transfusion * Use of oral iron supplements, EPO, in control patients is permitted. (no IV iron supplements)
干预措施: RBC (Drug)
结局指标
主要结局
transfusion rate
时间窗: within 3 weeks after surgery
Transfusion rate within 3 weeks after surgery, radiation and chemotherapy treatment
次要结局
- Quality of life of patients EORTC QLQ-C30(within 3 weeks after surgery)
- Quality of life of patients HINT-8(within 3 weeks after surgery)
- hemoglobin differences(within 3 weeks after surgery)
- Frequency of anemia(within 3 weeks after surgery)
- Frequency and delay period of treatment(within 3 weeks after surgery)
- The costs that patients actually pay for treatment (Cost-effectiveness)(within 3 weeks after surgery)
- Adverse events(within 3 weeks after surgery)
研究者
Jeong-Yeol Park, MD, PhD
Professor
Asan Medical Center
研究点 (1)
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