Organ Transplant
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESherpaPak™ 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.
OTHERCold Storage
FDA-approved method for organ procurement
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Re-do heart transplant * Multi-organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) | 24 hours post-transplant | Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle) |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | within 30 days | Hospital Length of Stay |
| Acute Cellular Rejection | 30 days | — |
| Cardiac Index | 24 hours post-transplant | — |
| Antibody Mediated Rejection | 30 days | — |
| pAMR 1 | 30 days | 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. |
| 1R | 30 days | 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 |
| 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 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Demographics for Recipient Standard Care Cold Storage Standard Care Cold Storage | 10 |
| Baseline Demographics for Recipient Sherpapak Baseline demographics for recipient Standard Care Cold Storage | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Baseline Demographics for Recipient Standard Care Cold Storage | Baseline Demographics for Recipient Sherpapak | Total |
|---|---|---|---|
| Age, Customized Age | 62 years STANDARD_DEVIATION 9.3 | 57.2 years STANDARD_DEVIATION 9.7 | 59.7 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Ethnicity (hispanic) | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Ethnicity (non-hispanic) | 6 Participants | 5 Participants | 11 Participants |
| Sex/Gender, Customized Sex (female) | 4 Participants | 2 Participants | 6 Participants |
| Sex/Gender, Customized Sex (male) | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 1 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 | 2 / 10 |
Outcome results
Primary
30-day Post-transplant Survival
Time frame: 30 day post heart transplant (htx)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | 30-day Post-transplant Survival | 10 Participants |
| Sherpapak Cardiac Transport | 30-day Post-transplant Survival | 9 Participants |
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)
Time frame: 24 hours post-transplant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) | 10 Participants |
| Sherpapak Cardiac Transport | Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) | 10 Participants |
Primary
Freedom From 30-day Any-treated Rejection
Time frame: 30 day post htx
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Freedom From 30-day Any-treated Rejection | 9 Participants |
| Sherpapak Cardiac Transport | Freedom From 30-day Any-treated Rejection | 8 Participants |
Primary
Freedom From 30-day Biopsy Proven Rejection
Time frame: 30 day post htx
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Freedom From 30-day Biopsy Proven Rejection | 9 Participants |
| Sherpapak Cardiac Transport | Freedom From 30-day Biopsy Proven Rejection | 8 Participants |
Primary
Freedom From 30-day Ischemic Reperfusion Injury
Time frame: 30 day post htx
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Freedom From 30-day Ischemic Reperfusion Injury | 10 Participants |
| Sherpapak Cardiac Transport | Freedom From 30-day Ischemic Reperfusion Injury | 8 Participants |
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | 1R | 5 Participants |
| Sherpapak Cardiac Transport | 1R | 3 Participants |
Secondary
Acute Cellular Rejection
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Acute Cellular Rejection | 5 Participants |
| Sherpapak Cardiac Transport | Acute Cellular Rejection | 3 Participants |
Secondary
Antibody Mediated Rejection
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | Antibody Mediated Rejection | 1 Participants |
| Sherpapak Cardiac Transport | Antibody Mediated Rejection | 1 Participants |
Secondary
Cardiac Index
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Cardiac Index | 3.1 L/min/m^2 | Standard Deviation 1.2 |
| Sherpapak Cardiac Transport | Cardiac Index | 3.5 L/min/m^2 | Standard Deviation 1.1 |
Secondary
Cardiac Output
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Cardiac Output | 5.6 L/min | Standard Deviation 1.3 |
| Sherpapak Cardiac Transport | Cardiac Output | 6.5 L/min | Standard Deviation 2.3 |
Secondary
Hospital Length of Stay
Hospital Length of Stay
Time frame: within 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Hospital Length of Stay | 15.1 days | Standard Deviation 8 |
| Sherpapak Cardiac Transport | Hospital Length of Stay | 21.1 days | Standard Deviation 14 |
Secondary
Mean Arterial Pressure
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Mean Arterial Pressure | 79 mmHg | Standard Deviation 8 |
| Sherpapak Cardiac Transport | Mean Arterial Pressure | 83 mmHg | Standard Deviation 14 |
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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Cold Storage | pAMR 1 | 1 Participants |
| Sherpapak Cardiac Transport | pAMR 1 | 1 Participants |
Secondary
Pulmonary Arterial Pressure
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Pulmonary Arterial Pressure | 25 mmHg | Standard Deviation 2 |
| Sherpapak Cardiac Transport | Pulmonary Arterial Pressure | 22 mmHg | Standard Deviation 6 |
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)
Time frame: 24 hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Cold Storage | Vasoactive-Inotropic Score | 264.1 score on a scale | Standard Deviation 218 |
| Sherpapak Cardiac Transport | Vasoactive-Inotropic Score | 395.3 score on a scale | Standard Deviation 418 |