NCT00855712已完成不适用
Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TransMedics
- 入组人数
- 128
- 试验地点
- 20
- 主要终点
- 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
研究概览
简要总结
The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient Day of Transplant
- •Registered male or female primary heart transplant candidate
- •≥18 years old
- •Signed, written informed consent document and authorization to use and disclose protected health information
- •Donor Hearts
- •<60 years old
- •Mean systolic blood pressure >60 mmHg at the time of final heart assessment
- •Satisfactory echocardiography assessment defined as:
- •Ejection fraction >40%
- •Absence of severe segmental wall motion abnormalities
- •Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness <1.3 cm)
- •Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)
排除标准
- •Recipient Day of Transplant
- •>4 previous sternotomies
- •Chronic renal failure as defined by chronic serum creatinine >3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload)
- •Ventilator dependence at the time of transplant
- •Use of a ventricular assist device for > 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia
- •Panel reactive antibodies > 40% with a positive prospective cross match and/or virtual cross match
- •Use of an investigational drug or device, other than OCS, during the study.
- •Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant
- •Donor Hearts
- •Abnormal coronary angiogram defined as >50% stenosis, requiring coronary bypass
- •Donor-to-recipient body weight ratio of <0.6
- •Inotrope support at time of final heart assessment including, but not limited to:
- •Dopamine >10 ug/kg/min
- •Dobutamine > 10 ug/kg/min
- •Milrinone >0.3 ug/kg/min
- •Epinephrine > 0.03 ug/kg/min
- •Norepinephrine > 0.03 ug/kg/min
- •Any bolus dose of the above prior to explants that would result in exceeding the above stated criteria
- •Presence of any exclusion criterion based on the standard practice of the investigational site
结局指标
主要结局
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
时间窗: 30 days
次要结局
- Incidence of all cardiac graft-related serious adverse events(30 days)
- Length of ICU stay(30 day)
- Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up(30 day)
研究者
研究点 (20)
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