CTIS2023-510492-57-00招募中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 (CL-N-HTX-Paed-II/10/20) - CL-N-HTX-Paed
Dr. Franz Koehler Chemie GmbH0 个研究点目标入组 15 人开始时间: 2024年4月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 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
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Patient criteria: Age from birth to less than18 years, Patient critera: Recipients awaiting their first transplant, Patient criteria: Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial, Patient criteria: written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study), Patient criteria: Patient listed on the waiting list for heart transplantation, Donor criteria: deceased donors should fulfil the standard criteria for organ donation (SCD)
排除标准
- •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, Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
研究者
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