EUCTR2010-022660-12-DE进行中（未招募）1 期
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 University0 个研究点目标入组 430 人开始时间: 2010年11月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Full-size liver transplantation
- •2. Informed consent of the patient or legal representative
- •3. Age = 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 370
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Women of child-bearing potential except women with the following criteria:
- •- post menopausal (12 month natural amenorrhoe or 6 month amenorrhoe with serum FSH > 40 mlU/ml)
- •- sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy
- •- 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
- •- sexual abstinence
- •- vasectomised partner
- •2. Pregnancy/lactation
- •3. Respiratory and/or circulatory instability (noradrenaline > 1 µg/kgBW/min and FiO2 > 0.6) after LTx before randomization
- •4. Split liver transplantation / living donor related liver transplantation
- •5. Retransplantation
- •6. Multivisceral 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 Iloprost 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 II-IV)
- •13. Cardiac arrhythmias relevant for the prognosis
- •14. Suspected pulmonary artery congestion
- •15. known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids
研究者
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