A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children
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
- adverse event reporting
研究概览
简要总结
The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to <18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:
to compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.
Participants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.
详细描述
Orthotopic Heart transplantation (or cardiac transplantation) is a procedure performed in patients with end stage heart failure when other treatments have failed.
The surgical procedures for orthotopic heart transplantation are essentially the same in adult and paediatric patients . Due to anatomical variants in congenital heart disease the procurement procedure may be modified with regard to the extent of the Vena cava superior and the great vessels. In implantation most frequently the bicaval technique is used but the biatrial technique which is leaving the back wall of both atria in situ may also be employed.
A main difference between adult and paediatric heart transplantation (HTx) are the indications for transplantation: In adults the majority of patients undergo HTx as treatment of end stage heart failure due to cardiomyopathy or severe coronary artery disease when other treatments have failed. Infants younger than one year of age congenital heart disease (CHD) is the most common diagnosis representing more than every second case followed by dilated cardiomyopathy (DCM) in more than one third of cases. In older patients DCM is the most frequent underlying diagnosis. CHD may include patients who have undergone corrective surgery and in whom myocardial dysfunction develops later .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient and their legal representatives will be blinded to treatment. All other parties are unblinded.
入排标准
- 年龄范围
- 24 Hours 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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
- •Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities
- •Pregnancy and lactation
研究组 & 干预措施
Custodiol-N
organ will be perfused with Custodiol-N solution
干预措施: Custodiol-N (Drug)
Custodiol
organ will be perfused with Custodiol solution
干预措施: Custodiol (Drug)
结局指标
主要结局
adverse event reporting
时间窗: up to 3 months
Safety assessment
次要结局
- heart rate(up to day 7 after release of the aortic cross clamp)
- blood pressure (systolic (SBP) and diastolic (DBP))(up to day 7 after release of the aortic cross clamp)
- body temperature(up to day 7 after release of the aortic cross clamp)
- Heart Rhythm (HR)(from termination of cardiopulmonary bypass until transfer to intensive care unit)
- Milrinone support(up to day 7)
- Ejection fraction(up to day 7)
- enddiastolic and endsystolic ventricle(up to day 7)
- (SBP (systolic blood pressure), DBP (diastolic blood pressure))(from termination of cardiopulmonary bypass until transfer to intensive care unit)
- Pulmonary artery pressure (PAP (if available))(from termination of cardiopulmonary bypass until transfer to intensive care unit)
- Death(up to 12 months)
- Catecholamine requirement(up to day 7)
- Antihypertensives intake(up to 12 months)
- concentration of cardiac troponin(up to day 7 after release of the aortic cross clamp)
- concentration of creatinine kinase (CK-MB)(up to day 7 after release of the aortic cross clamp)
- Need for pacemaker therapy(up to day 7)
- Cardiac arrhythmias(up to day 7)
- Cerebrovascular resistance (CVP (if available))(from termination of cardiopulmonary bypass until transfer to intensive care unit)
- function of transplanted organ (heart)(up to 12 months)
- Readmission to intensive care unit (ICU)(up to 12 months)
- Length of ICU stays(up to 12 months)
- Left and right ventricular assist device (LVAD, RVAD)(up to 12 months)
- Extracorporeal membrane oxygenation (ECMO)(up to 12 months)
- Biventricular assist Device (BIVAD) or percutaneous LVAD(up to 12 months)