Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)
研究概览
简要总结
The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts.
There are two methods of organ preservation. The first method is the use of cold storage. With this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts. This is also known as "standard of care."
The second method is the use of the SherpaPak™ Cardiac Transport System. With this method, the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts.
The study will include up to 20 people in total.
详细描述
This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio.
- 50% chance of receiving a donor heart using the SherpaPak™ method, or
- 50% chance of receiving a donor heart using the cold storage method.
The research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. Participants will be in the study for about 30 days.
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
- 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
- •Any sex/gender, 18 years of age or older listed for primary heart transplant.
- •Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
- •Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
- •Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies)
排除标准
- •Re-do heart transplant
- •Multi-organ transplant
结局指标
主要结局
Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)
时间窗: 24 hours post-transplant
Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)
30-day Post-transplant Survival
时间窗: 30 day post heart transplant (htx)
Freedom From 30-day Ischemic Reperfusion Injury
时间窗: 30 day post htx
Freedom From 30-day Biopsy Proven Rejection
时间窗: 30 day post htx
Freedom From 30-day Any-treated Rejection
时间窗: 30 day post htx
次要结局
- Cardiac Index(24 hours post-transplant)
- Cardiac Output(24 hours post-transplant)
- Mean Arterial Pressure(24 hours post-transplant)
- Pulmonary Arterial Pressure(24 hours post-transplant)
- Vasoactive-Inotropic Score(24 hours post-transplant)
- Hospital Length of Stay(within 30 days)
- Acute Cellular Rejection(30 days)
- 1R(30 days)
- Antibody Mediated Rejection(30 days)
- pAMR 1(30 days)
研究者
Fardad Esmailian
Professor of Surgery
Cedars-Sinai Medical Center