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临床试验/JPRN-UMIN000031029
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

发起方
Seirei Hospice, Seirei Mikatahara General Hospital

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