EUCTR2022-001795-34-DE进行中（未招募）1 期
A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •Patient criteria:
- •- Age from birth to less than18 years
- •- Recipients awaiting their first transplant
- •- Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial
- •- written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study)
- •- Patient listed on the waiting list for heart transplantation
- •Donor criteria:
- •- deceased donors should fulfil the standard criteria for organ donation (SCD)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient criteria:
- •- Patients who have participated within 30 days or are still participating in any other interventional studies
- •- history of severe organic disease other than concerning the heart
- •- history/demonstration of HIV antibodies or AIDS
- •- multiorgan transplantation
- •- machine-perfused organ
- •- the explantation team is affiliated to another clinic than transplantation team
- •-Failing Fontan patients
- •-Pregnancy and lactation
研究者
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