EUCTR2012-001960-31-BE进行中（未招募）1 期
Combined drug Approach to Prevent Ischemia-reperfusion injury during Transplantation of Livers (CAPITL): a first-in-men study - CAPITL study
Z Leuven0 个研究点目标入组 82 人开始时间: 2013年2月4日最近更新:
适应症
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
- 82
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
- •- Older than 18 years,
- •-Patients undergoing liver transplantation in University Hospitals Leuven, Centre Hospitalier Universitaire de Liège and at other national and international centers.
- •-Patient must have signed the patient informed consent,
- •-All donor types: donation after brain death (DBD), donation after cardiac death (DCD), standard criteria donors (SCD) and extended criteria donors (ECD) defined according Paris consensus
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Patients who refuse to participate in the study,
- •- History of hypersensitivity to anti-thrombin III (Atenativ®), C1-inhibitor (Cetor®/Cinryze®), melatonin (Circadin®), epoprostenol (Flolan®), recombinant human EPO (Neorecormon®), infliximab (Remicade®), glutathione (Tationil®), tocopferol (vitamin e suspension 100 mg/mL®) will be excluded from the treatment group.
- •- Conditions that prevent the use of the multifactorial modulation:
- •- Administration of heparin at therapeutic dose pre-operatively: anti-thrombin III (Atenativ®), epoprostenol (Flolan®).
- •- Congestive heart failure arising from severe left ventricular dysfunction: epoprostenol (Flolan®), infliximab (Remicade®).
- •- History of seizures (not related to the underlying liver disease or to metabolic disturbances secondary to liver cirrhoris and to be distuinghuised from e.g. hepatic encephalopathy), poorly controlled arterial hypertension, myocardial infarction or stroke in the month preceding the liver transplantation, and history of pre-existing venous thromboembolic disease which is not related to liver cirrhosis and hypercoagulability (eg. partial, complete or previous vena porta thrombosis/ vena mesenterica thrombosis/ vena lienalis): recombinant human EPO (Neorecormon®).
- •- Unstable angina pectoris: recombinant human EPO (Neorecormon®).
- •- Severe untreated infections such as sepsis, abscesses and opportunistic infections: infliximab (Remicade®).
- •- Use of Vitamin K antagonist anticoagulation preoperatively which can not be reversed, women taking oral contraceptives containing oestrogens: tocopferol (vitamin E suspension 100 mg/mL®).
- •- Patients with previous treatment of infliximab (Remicade®),
- •Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial,
- •- Combined organ transplantation,
- •- Re-transplantation,
- •- Patients that are dialysis-dependent prior to LTx,
- •- LTx from a living or a split organ donation
- •- Administration of the multifactorial modulation technically non-feasible (i.e impossibility to place the second central catheter required for the separate and sequential injection of the different components of the multifactorial modulation).
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