2023-510492-57-00招募中2 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)
Dr. Franz Koehler Chemie GmbH3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年5月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Safety assessment, i.e. continuous adverse event reporting up to 3 months
研究概览
简要总结
The objective of this investigation is to compare the safety of two organ preservation solutions,Custodiol and Custodiol-N, in paediatric patients undergoing heart transplantation Primary: Safety assessment, i.e. continuous adverse event reporting up to 3 months
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Safety assessment, i.e. continuous adverse event reporting up to 3 months
Safety assessment, i.e. continuous adverse event reporting up to 3 months
次要结局
- Vital parameters (heart rate, blood pressure, body temperature) up to day 7
- Laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7o CK-MB peak value from 4 to 168 hours after release of the aortic cross clamp (measurements 4,8,12,16,20,24± 30min; 32h,40h,48h,56h,64h,72h ± 2 hours; visit 4-7 one time/interval) o CK-MB AUC value visit 1-7 o Troponin T up to 168 hours after release of the aortic cross clamp (measurements 4,8,12,16,20,24hours ± 30 min;32h,40h,48h,56h,64h,72h ± 2hours; visit 4-7 one time/interval) o Troponin AUC value visit 1-7
- Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation.
- Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to intensive care unit (SBP, DBP), HR, PAP (if available), CVR (if available)
- Death up to 3 months
- Graft survival up to 12 months
- Readmission to ICU up to 12 months
- Length of ICU stays up to 12 months
- Catecholamine requirement (yes/no) up to day 7
- Antihypertensiva intake (yes/no) up to 3 months
- Milrinone support (yes/no) up to day 7
- Need for pacemaker therapy (yes/no) up to day 7 and up to 12 months
- Device therapy (each yes/no) up to 12 months (including LVAD, RVAD,ECMO, BIVAD or percutaneuos LVAD)
- Echocardiographic markers of function and rejection up to day 7 (Ejection fraction, enddiastolic and endsystolic ventricle volume)
- Cardiac arrhythmias up to day 7 (occurrence, severity, type)
研究者
Christoph Knosalla
Scientific
Dr. Franz Koehler Chemie GmbH
研究点 (3)
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