Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors Compared to Donor Hearts From Donation After Brain Death (DBD) Donors: A Single Center Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation.
研究概览
简要总结
The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.
详细描述
In the U.S., heart donation occurs after a person has been declared brain dead and is called a donor after brain death (DBD). In these patients, the heart continues to beat and pump blood throughout the body. After life support is withdrawn, organs are retrieved immediately for transplantation. This study will use hearts from donors after circulatory death (DCD) donors. DCD donors are those whose hearts have stopped beating and no longer pump blood. DCD hearts are not used as often for transplantation today in the U.S. because they may be further injured during traditional cold storage. In the US, donor hearts are currently mostly obtained from donors after brain death (DBD), although DCD donors are used for other donated organs, such as: lungs, kidneys, and livers.
This study will evaluate whether patients who receive a DCD heart transplant using either NRP or DPP have similar outcomes as patients who receive DBD hearts using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center. Ten (10) DCD donor heart recipients will be enrolled into the study intervention group, and approximately 30 DBD donor heart recipients will be enrolled into the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Recipient Inclusion Criteria:
- •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
- •Male or female, aged 18 years of age or older listed for primary heart transplant
排除标准
- •Prior history of cardiac transplantation
- •Multi-organ transplant
- •Current or planned participation in another interventional trial
- •Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
研究组 & 干预措施
DCD Donor Heart Transplantation
If the heart offer is from a DCD donor, the heart will be retrieved using one of two strategies: Normothermic Regional Perfusion (NRP) or Direct Procurement and Perfusion (DPP). NRP procedures will be used to procure all DCD hearts unless contraindicated or prohibited by the donor hospital. In the event the donor hospital does not allow NRP for cardiac organ procurement, or the target number of eight DCD transplants with NRP has been achieved, DPP with the Organ Care System (OCS) should be utilized.
干预措施: DCD Donor Heart Transplantation (Device)
DBD Donor Heart Transplantation
If the heart offer is from a DBD donor, the heart will be retrieved per standard of care.
干预措施: DBD Donor Heart Transplantation (Other)
结局指标
主要结局
Evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation.
时间窗: 30 days post-heart transplant
Percentage of subjects with incidence of heart graft-related Serious Adverse Events (HGRSAEs) in the DCD Heart Transplanted Recipient Population
The Primary Objective of This Proposed Research is to Evaluate the Safety of Utilizing DCD Donor Hearts as Compared to DBD Donor Hearts for Transplantation.
时间窗: 30 days post-heart transplant
The primary objective of this proposed research is to evaluate the safety of utilizing DCD donor hearts as compared to DBD donor hearts for transplantation HGRSAE (Heart Graft Related Serious Adverse Event) in the first 30 days post-transplan
Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant
时间窗: 30 days post transplant
Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS
次要结局
- Assess the practical, financial and logistical viability of using NRP vs. DPP for the procurement of DCD donor hearts.(1 year)
- The Secondary Objective is to Assess the Practical, Financial and Logical Viability of Using NRP vs. DPP for the Procurement of DCD Donor Hearts(Time on waitlist)
研究者
Fardad Esmailian
Surgical Director, Heart Transplantation and Mechanical Circulatory Support
Cedars-Sinai Medical Center