Trial Outcomes & Findings for Trial to Compare the SherpaPak™ Device vs Cold Storage (NCT NCT05194514)

NCT ID: NCT05194514

Last Updated: 2025-02-21

Results Overview

Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 hours post-transplant
• Results posted on: 2025-02-21

Participant Flow

Participant milestones

Measure	Cold Storage Subjects that received donor hearts preserved with cold storage	SherpaPak Subjects who received donor hearts preserved through SherpaPak
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial to Compare the SherpaPak™ Device vs Cold Storage

Baseline characteristics by cohort

Measure	Baseline Demographics for Recipient Standard Care Cold Storage n=10 Participants Standard Care Cold Storage	Baseline Demographics for Recipient Sherpapak n=10 Participants Baseline demographics for recipient Standard Care Cold Storage	Total n=20 Participants Total of all reporting groups
Age, Customized Age	62 years STANDARD_DEVIATION 9.3 • n=5 Participants	57.2 years STANDARD_DEVIATION 9.7 • n=7 Participants	59.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex/Gender, Customized Sex (male)	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex/Gender, Customized Sex (female)	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity (non-hispanic)	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity (hispanic)	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post-transplant

Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)	10 Participants	10 Participants

PRIMARY outcome

Timeframe: 30 day post heart transplant (htx)

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
30-day Post-transplant Survival	10 Participants	9 Participants

PRIMARY outcome

Timeframe: 30 day post htx

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Freedom From 30-day Ischemic Reperfusion Injury	10 Participants	8 Participants

PRIMARY outcome

Timeframe: 30 day post htx

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Freedom From 30-day Biopsy Proven Rejection	9 Participants	8 Participants

PRIMARY outcome

Timeframe: 30 day post htx

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Freedom From 30-day Any-treated Rejection	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 24 hours post-transplant

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Cardiac Index	3.1 L/min/m^2 Standard Deviation 1.2	3.5 L/min/m^2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: 24 hours post-transplant

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Cardiac Output	5.6 L/min Standard Deviation 1.3	6.5 L/min Standard Deviation 2.3

SECONDARY outcome

Timeframe: 24 hours post-transplant

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Mean Arterial Pressure	79 mmHg Standard Deviation 8	83 mmHg Standard Deviation 14

SECONDARY outcome

Timeframe: 24 hours post-transplant

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Pulmonary Arterial Pressure	25 mmHg Standard Deviation 2	22 mmHg Standard Deviation 6

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Vasoactive-Inotropic Score	264.1 score on a scale Standard Deviation 218	395.3 score on a scale Standard Deviation 418

SECONDARY outcome

Timeframe: within 30 days

Hospital Length of Stay

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Hospital Length of Stay	15.1 days Standard Deviation 8	21.1 days Standard Deviation 14

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Acute Cellular Rejection	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Standard Care Cold Storage n=5 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=3 Participants 100% freedom from severe primary graft dysfunction
1R	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Standard Care Cold Storage n=10 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=10 Participants 100% freedom from severe primary graft dysfunction
Antibody Mediated Rejection	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard Care Cold Storage n=1 Participants 100% freedom from severe primary graft dysfunction	Sherpapak Cardiac Transport n=1 Participants 100% freedom from severe primary graft dysfunction
pAMR 1	1 Participants	1 Participants

Adverse Events

Standard Care Cold Storage

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Sherpapak Cardiac Transport

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Standard Care Cold Storage n=10 participants at risk Patients who received standard care cold storage	Sherpapak Cardiac Transport n=10 participants at risk Patients who received Sherpapak Cardiac Transport
Infections and infestations Epyema	0.00% 0/10 • Within 30 days post transplant	10.0% 1/10 • Within 30 days post transplant
Cardiac disorders Death	0.00% 0/10 • Within 30 days post transplant	10.0% 1/10 • Within 30 days post transplant
Surgical and medical procedures Mediastinal Bleeding	10.0% 1/10 • Within 30 days post transplant	0.00% 0/10 • Within 30 days post transplant

Other adverse events

Adverse event data not reported

Additional Information

Fardad Esmailian

Cedars-Sinai

Phone: 310-248-7132

Email: fardad.esmailian@cshs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place