JPRN-jRCTs041230111招募中1 期
Phase I Trial on the Safety of Olprinone for Low Central Venous Pressure Management Aimed at Hemorrhage Control During Open Hepatectomy
Sugiura Teiichi0 个研究点目标入组 30 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) An open hepatectomy is scheduled.
- •(2) The registered age is between 18 and 75 years old.
- •(3) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1.
- •(4) There's no obstructive ventilatory impairment (Forced Expiratory Volume in 1 second (FEV1.0%) is >= 70%).
- •(5) There's no history of angina or myocardial infar ction.
- •(6) No moderate to severe valvular disease (based on the findings from a transthoracic echocardiogram).
- •(7) All the following conditions are met:
- •White blood cell count: between 2,500/mm3 and 10,000/mm3
- •Platelet count >=100,000/mm3
- •AST <=100IU/L
- •ALT <=100IU/L
- •Total bilirubin <=2.0 mg/dL (<=4.0mg/dL in cases with jaundice)
- •Serum creatinine <=1.0mg/dL
- •(8) Written consent for trial participation has been obtained from the patient.
排除标准
- •(1) Cases with a history of arrhythmia. (Premature ventricular contractions are not included.)
- •(2) Cases where surgery is conducted without discontinuing antiplatelet drugs.
- •(3) Cases with a history of hypersensitivity to PDEIII inhibitors.
- •(4) Cases deemed unsuitable for this trial by the at tending physician.
研究者
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