JPRN-UMIN000031029已完成未知
Feasibility of a fast-track randomised controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites - Feasibility of a fast-track RCT of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
Seirei Hospice, Seirei Mikatahara General Hospital0 个研究点目标入组 20 人开始时间: 2018年2月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Of 20 patients allocated, 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patient who received chemotherapy, immunotherapy, hormonal therapy, or abdominal radiotherapy in the previous 28 days. 2. Patient who have systemic infections or abdominal infections. 3. Patient who generate fever >= 38 degree celsius. 4. Patient whose systolic blood pressure < 80mmHg. 5. Hemoglobine <6.0 mg/dL Creatinine >= 2.0ug/dL Total bilirubine >= 5.0mg/dL 6. Patient who have history of hepatic encephalopathy. 7. Patient who have cognitive inpairement. 8. Patient without any intravenous line. 9. Other reasons by which physicians judge they are ineligible.
研究者
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