Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of primary graft dysfunction
研究概览
简要总结
The investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.
详细描述
The purpose of this study is to compare outcomes following heart transplant using two different storage devices for transport of the donor heart, an adjustable temperature cooler or a commercially available storage device called the Paragonix SherpaPak.
When a donor heart is identified for transplant, the method of storage during transportation will be randomized to one of two different options for cold storage. All other parts of the participant's care will then continue per usual standard of care. In the thirty days following transplant, the research team will review the participant's medical record to see what medications were used after transplant, what diagnostic studies like echocardiograms showed, and to collect basic information about the participant's medical history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 18 years old or older are included.
- •Individuals undergoing isolated heart transplantation are included.
排除标准
- •Any records flagged "break the glass" or "research opt out."
- •Any patients undergoing multi-organ transplantation.
研究组 & 干预措施
Organ transport using Standard of Care Paragonix SherpaPak
In this arm, the organ will be transported using the FDA Approved Sheperpak by Paragonix
干预措施: Organ transport using SherpaPak (Device)
Organ transport using the RYOBI cooler.
In this arm, the organ will be transported using the Ryobi cooler
干预措施: Ryobi cooler for Organ Transport (Device)
结局指标
主要结局
Incidence of primary graft dysfunction
时间窗: From Randomization to 30 days after heart transplantation
compare the incidence of primary graft dysfunction between patients randomized to donor heart preservation using the adjustable temperature RYOBI cooler (Model # Pi1824QBT) (n = 40) versus the Paragonix SherpaPak (n = 40) in cases where the anticipated total ischemic time for the graft is between 120 and 240 minutes.
次要结局
未报告次要终点
研究者
Dominic Emerson, MD
Associate Surgical Director of Heart Transplant and Mechanical Circulatory Support, Director of Robotic Cardiac Surgery, and Director of the Accreditation Council for Graduate Medical Education Fellowship Program
Cedars-Sinai Medical Center