Organ Transplant
Conditions
Brief summary
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.
Detailed description
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 After life support is withdrawn, organs are retrieved immediately for transplantation.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.
Interventions
OTHERDBD Donor Heart Transplantation
A technique of donor heart procurement.
DEVICEDCD Donor Heart Transplantation
A technique of donor heart procurement. The TransMedics' OCS Heart technology is the only portable system available for ex-vivo maintenance of the donor heart in a metabolically active and beating state. It is currently FDA approved for procurement and transport.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Inclusion Criteria: 1. 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. 2. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information 3. Male or female, aged 18 years of age or older listed for primary heart transplant Recipient
Exclusion criteria
1. Prior history of cardiac transplantation 2. Multi-organ transplant 3. Current or planned participation in another interventional trial 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 30 days post transplant | Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | The secondary objective is to assess the practical, financial and logical viability of using NRP vs. DPP for the procurement of DCD donor hearts in this study. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFardad Esmailian, MD
Cedars-Sinai Medical Center
Participant flow
Pre-assignment details
Donors are not considered enrolled. Only recipients.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Age of donor heart received. | 36 Years |
| Age, Continuous Recipient age at transplant | 59 Years |
| Chronic Kidney Disease | 5 Participants |
| Diabetes Mellitus | 18 Participants |
| Hypertension | 4 Participants |
| Ischemic time (Minutes, Median [Q1-Q3]) | 192 Minutes |
| Ischemic vs. Non-ischemic Cardiomyopathy Ischemic cardiomyopathy | 12 Participants |
| Ischemic vs. Non-ischemic Cardiomyopathy Non-ischemic cardiomyopathy | 18 Participants |
| Pre-transplant Blood Transfusion | 2 Participants |
| Pre-transplant Durable Mechanical Circulatory Support placement | 7 Participants |
| Pre-transplant Panel Reactive Antibody ≥ 10% | 1 Participants |
| Pre-transplant Pregnancy in Females | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Recipient Aortic Cross-clamping Total Time (Minutes, Median [Q1-Q3]) | 80 Minutes |
| Recipient Blood Type A | 6 Participants |
| Recipient Blood Type AB | 2 Participants |
| Recipient Blood Type B | 0 Participants |
| Recipient Blood Type O | 15 Participants |
| Recipient Cardiopulmonary Bypass Total Time (Minutes, Median [Q1-Q3]) | 149.5 Minutes |
| Sex/Gender, Customized Recipient gender female | 1 Participants |
| Sex/Gender, Customized Recipient gender male | 18 Participants |
| Total time on transplant waitlist (Days, Median [Q1-Q3]) | 12 Days |
| Transplant Operating Room Total Time (Minutes, Median [Q1-Q3]) | 536 Minutes |
| Urgent status at Transplant | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 10 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 5 / 30 | 1 / 10 |
Outcome results
None listed