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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.
This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SherpaPak™ Cardiac Transport System | Other | When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. |
|
| Cold Storage | Other | When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SherpaPak™ Device | Device | The SherpaPak™ Cardiac Transport System has been developed to provide a safe, consistent method for cold ischemic storage of donor hearts for transplantation. This device is FDA approved. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) | Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle) | 24 hours post-transplant |
| 30-day Post-transplant Survival | 30 day post heart transplant (htx) | |
| Freedom From 30-day Ischemic Reperfusion Injury | 30 day post htx | |
| Freedom From 30-day Biopsy Proven Rejection | 30 day post htx | |
| Freedom From 30-day Any-treated Rejection | 30 day post htx |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Index | 24 hours post-transplant | |
| Cardiac Output | 24 hours post-transplant | |
| Mean Arterial Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fardad Esmailian | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
Data that underlies the results reported in this article, after deidentification.
1 year after the study is closed.
Researchers who provide a methodologically sound proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cold Storage | Subjects that received donor hearts preserved with cold storage |
| FG001 | SherpaPak | Subjects who received donor hearts preserved through SherpaPak |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Demographics for Recipient Standard Care Cold Storage | Standard Care Cold Storage |
| BG001 | Baseline Demographics for Recipient Sherpapak | Baseline demographics for recipient Standard Care Cold Storage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) | Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle) | Posted | Count of Participants | Participants | 24 hours post-transplant |
|
Within 30 days post transplant
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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 | Standard Care Cold Storage | Patients who received standard care cold storage | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epyema | Infections and infestations | Systematic Assessment |
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There are several limitations to our study. First, the small sample size limits our ability to detect clinical differences between the groups. Second, our primary clinical end points were only followed out to 30-days warranting further randomized trials aimed at assessing the long-term effects on clinical outcomes. Third, cardiac samples have a high dynamic range of proteins due to the abundance of contractile machinery within cardiomyocytes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fardad Esmailian | Cedars-Sinai | 310-248-7132 | fardad.esmailian@cshs.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 | Feb 16, 2022 | Aug 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2022 | Aug 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015925 | Cryopreservation |
| ID | Term |
|---|---|
| D014021 | Tissue Preservation |
| D016591 | Histocytological Preparation Techniques |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Cold Storage | Other | FDA-approved method for organ procurement |
|
| 24 hours post-transplant |
| Pulmonary Arterial Pressure | 24 hours post-transplant |
| Vasoactive-Inotropic Score | Vasoactive inotropic scores (VIS) are used to measure the amount of cardiovascular support a patient is receiving at certain time point, for our study it was at 24hrs post transplant. Below is the calculation for the score. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min). The minimum score is 0 if the patient does not require any support but there really isn't a maximum score as theoretically patients can be on any range of support. Higher values indicates that a patient is requiring a higher cardiovascular support at 24 hrs. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min) | 24 hours post-transplant |
| Hospital Length of Stay | Hospital Length of Stay | within 30 days |
| Acute Cellular Rejection | 30 days |
| 1R | 1R is the rejection grade that referring to mild cellular rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild cellular mediated damage (interstitial/perivascular inflammation) using special stains. Only participants with acute cellular rejection were assessed for this Outcome Measure | 30 days |
| Antibody Mediated Rejection | 30 days |
| pAMR 1 | pAMR1 is the rejection grade that referring to mild antibody rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild antibody-mediated damage using special stains to detect the presence of immune complexes. | 30 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 30-day Post-transplant Survival | Posted | Count of Participants | Participants | 30 day post heart transplant (htx) |
|
|
|
| Primary | Freedom From 30-day Ischemic Reperfusion Injury | Posted | Count of Participants | Participants | No | 30 day post htx |
|
|
|
| Primary | Freedom From 30-day Biopsy Proven Rejection | Posted | Count of Participants | Participants | 30 day post htx |
|
|
|
| Primary | Freedom From 30-day Any-treated Rejection | Posted | Count of Participants | Participants | No | 30 day post htx |
|
|
|
| Secondary | Cardiac Index | Posted | Mean | Standard Deviation | L/min/m^2 | 24 hours post-transplant |
|
|
|
| Secondary | Cardiac Output | Posted | Mean | Standard Deviation | L/min | 24 hours post-transplant |
|
|
|
| Secondary | Mean Arterial Pressure | Posted | Mean | Standard Deviation | mmHg | 24 hours post-transplant |
|
|
|
| Secondary | Pulmonary Arterial Pressure | Posted | Mean | Standard Deviation | mmHg | 24 hours post-transplant |
|
|
|
| Secondary | Vasoactive-Inotropic Score | Vasoactive inotropic scores (VIS) are used to measure the amount of cardiovascular support a patient is receiving at certain time point, for our study it was at 24hrs post transplant. Below is the calculation for the score. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min). The minimum score is 0 if the patient does not require any support but there really isn't a maximum score as theoretically patients can be on any range of support. Higher values indicates that a patient is requiring a higher cardiovascular support at 24 hrs. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min) | Posted | Mean | Standard Deviation | score on a scale | 24 hours post-transplant |
|
|
|
| Secondary | Hospital Length of Stay | Hospital Length of Stay | Posted | Mean | Standard Deviation | days | within 30 days |
|
|
|
| Secondary | Acute Cellular Rejection | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 1R | 1R is the rejection grade that referring to mild cellular rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild cellular mediated damage (interstitial/perivascular inflammation) using special stains. Only participants with acute cellular rejection were assessed for this Outcome Measure | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Antibody Mediated Rejection | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | pAMR 1 | pAMR1 is the rejection grade that referring to mild antibody rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild antibody-mediated damage using special stains to detect the presence of immune complexes. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Sherpapak Cardiac Transport | Patients who received Sherpapak Cardiac Transport | 1 | 10 | 2 | 10 | 0 | 10 |
| Death | Cardiac disorders | Systematic Assessment |
|
| Mediastinal Bleeding | Surgical and medical procedures | Systematic Assessment | Surgical complication |
|
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D011309 | Preservation, Biological |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |