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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.
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 After life support is withdrawn, organs are retrieved immediately for transplantation.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBD Donor Heart Transplantation | Other | If the heart offer is from a DBD donor, the heart will be retrieved per standard of care. |
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| DCD Donor Heart Transplantation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBD Donor Heart Transplantation | Other | A technique of donor heart procurement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 30 days post-heart transplant |
| Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant | Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS | 30 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Objective is to Assess the Practical, Financial and Logical Viability of Using NRP vs. DPP for the Procurement of DCD Donor Hearts | 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. | Time on waitlist |
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Recipient Inclusion Criteria:
Recipient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fardad Esmailian, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
Donors are not considered enrolled. Only recipients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donation After Brain Death- Donor Heart Transplantation | If the heart offer is from a DBD donor, the heart will be retrieved per standard of care. DBD Donor Heart Transplantation: A technique of donor heart procurement. |
| FG001 | Donation After Circulatory Death- 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. DCD 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DBD Donor Heart Transplantation | If the heart offer is from a DBD donor, the heart will be retrieved per standard of care. DBD Donor Heart Transplantation: A technique of donor heart procurement. |
| BG001 | DCD Donor Heart Transplantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Count of Participants | Participants | 30 days post-heart transplant |
|
All heart graft-related serious adverse events are to be recorded on the electronic case report forms until post-transplant day 30 and up until discharge, maximum 88 days.
Only Serious Adverse Events (SAEs) and Heart Graft-Related Adverse Events (HGRAEs) will be captured in this study in a DCD vs. DBD specifically in a pre-specified reporting manner.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBD Donor Heart Transplantation | If the heart offer is from a DBD donor, the heart will be retrieved per standard of care. DBD Donor Heart Transplantation: A technique of donor heart procurement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary Graft Dysfunction (PGD) | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shruti Shantharam | Cedars-Sinai | 3102488365 | shruti.shantharam@csmns.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2022 | Jan 20, 2026 | Prot_SAP_002.pdf |
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| DCD Donor Heart Transplantation | Device | 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. |
|
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. DCD 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Continuous | Age of donor heart received. Donors were not considered enrolled | Median | Inter-Quartile Range | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Recipient Blood Type | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
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| Chronic Kidney Disease | Count of Participants | Participants |
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| Ischemic vs. Non-ischemic Cardiomyopathy | Count of Participants | Participants |
|
| Urgent status at Transplant | Count of Participants | Participants |
|
| Pre-transplant Pregnancy in Females | Only females were analyzed as this is a pregnancy metric | Count of Participants | Participants |
|
| Pre-transplant Durable Mechanical Circulatory Support placement | Count of Participants | Participants |
|
| Pre-transplant Panel Reactive Antibody ≥ 10% | Count of Participants | Participants |
|
| Total time on transplant waitlist (Days, Median [Q1-Q3]) | Median | Inter-Quartile Range | Days |
|
| Ischemic time (Minutes, Median [Q1-Q3]) | Median | Inter-Quartile Range | Minutes |
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| Transplant Operating Room Total Time (Minutes, Median [Q1-Q3]) | Median | Inter-Quartile Range | Minutes |
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| Recipient Aortic Cross-clamping Total Time (Minutes, Median [Q1-Q3]) | Median | Inter-Quartile Range | Minutes |
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| Recipient Cardiopulmonary Bypass Total Time (Minutes, Median [Q1-Q3]) | Median | Inter-Quartile Range | Minutes |
|
| Pre-transplant Blood Transfusion | Count of Participants | Participants |
|
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.
DCD 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.
|
|
| Primary | Primary Endpoints Comparing DBD vs. DCD-NRP vs. DCD-OCS (HGRSAE) in the First 30 Days Post-transplant | Primary endpoints comparing DBD vs. DCD-NRP vs. DCD-OCS | Posted | Count of Participants | Participants | 30 days post transplant |
|
|
|
| Secondary | The Secondary Objective is to Assess the Practical, Financial and Logical Viability of Using NRP vs. DPP for the Procurement of DCD Donor Hearts | 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. | Posted | Median | Inter-Quartile Range | Days | Time on waitlist |
|
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| 0 |
| 0 |
| EG001 | 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. DCD 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. | 0 | 10 | 1 | 10 | 0 | 0 |
| Use of post-transplant mechanical circulatory support for > 72 hours immediately post-transplant | Cardiac disorders | Systematic Assessment | Use of post-transplant mechanical circulatory support (ECMO, LVAD, RVAD, BiVAD) for > 72 hours immediately post-transplant. |
|
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| B |
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| O |
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| Patient and graft survival at 30-days |
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| Moderate or Severe Primary Graft Dysfunction |
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| Primary graft failure requiring re-transplantation |
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| Use of post transplant Mechanical Circulatory Support (ECMO, LVAD, RVAD, BiVAD) |
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| 30-day freedom from any-treated Rejection |
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| 30-day freedom from Acute Cellular Rejection (grade≥ 2R) |
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| 30-day freedom from Antibody-mediated rejection (pAMR≥1) |
|