DRKS00003514进行中（未招募）3 期
A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of Iloprost in the early postoperative period after liver transplantation - PRAISE-Study
Friedrich Schiller Universität Jena -Universitätsklinikum Jena0 个研究点目标入组 37 人开始时间: 2012年3月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Full-size liver transplantation
- •- Informed consent of the patient or legal representative
- •- Age = 18 years
排除标准
- •- Women of child-bearing potential except women with the following criteria:
- •o post menopausal (12 months natural amenorrhea or 6 month amenorrhea with serum FSH > 40 mlU/ml)
- •o sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy
- •o using an effective method of birth control for the duration of trial: implants, injectables, combined oral contraceptives, intra-uterine device (in place for a period of at least 2 months prior to screening) and with negative serum pregnancy test
- •o sexual abstinence
- •o vasectomised partner
- •- Pregnancy/lactation
- •- Respiratory and/or circulatory instability (noradrenaline > 1 µg/kgBW/min and FiO2 > 0.6) after LT before randomization
- •- Split liver transplantation/living donor related liver transplantation
- •- Retransplantation
- •- Receiving a multi-organ transplantation
- •- Participation on other clinical trials 30 days prior to randomization
- •- Known allergic reaction against trial medication
- •- Conditions in which bleeding complications may be expected from the effect of Iloprost on platelets
- •- Severe coronary artery disease or unstable angina pectoris
- •- Myocardial infarction within the past 6 months prior to baseline assessment after acceptance of donor organ
- •- Acute or chronic heart failure (NYHA II-IV)
- •- Cardiac arrhythmias relevant for the prognosis
- •- Suspected pulmonary artery congestion
- •- Known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids
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