ISRCTN12622749已完成未知
A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation
Friedrich-Schiller-University Jena (Germany)0 个研究点目标入组 356 人开始时间: 2012年10月2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
- 356
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 07/03/2013:
- •1. Full-size liver transplantation
- •2. Informed consent of the patient or legal representative
- •3. Aged 18 years or over
- •Previous inclusion criteria:
- •1. Full-size liver transplantation
- •2. Informed consent of the patient or legal representative
- •3. Age over 18 years
排除标准
- •1. Women of child-bearing potential except women with the following criteria:
- •1.1. Post menopausal (12 months natural amenorrhea or 6 month amenorrhea with serum FSH > 40 mlU/ml)
- •1.2. Sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy
- •1.3. Using an effective method of birth control for the duration of trial:
- •1.3.1 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
- •1.4. Sexual abstinence
- •2. Pregnancy/lactation
- •3. Respiratory and/or circulatory instability (noradrenaline > 1 pg/kgBWmin and FiOz > 0.6) after liver transplantation (LT) before randomization
- •4. Split liver transplantation/living donor related liver transplantation
- •5. Retransplantation
- •6. Receiving a multi-organ transplantation
- •7. Participation on other clinical trials 30 days prior to randomization
- •8. Known allergic reaction against trial medication
- •9. Conditions in which bleeding complications may be expected from the effect of lloprost on platelets
- •10. Severe coronary artery disease or unstable angina pectoris
- •11. Myocardial infarction within the past 6 months prior to baseline assessment after acceptance of donor organ
- •12. Acute or chronic heart failure (NYHA ll-lV)
- •13. Cardiac arrhythmias relevant for the prognosis
- •14. Suspected pulmonary artery congestion
- •15. Known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids
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