Trial Outcomes & Findings for Hypothermic Machine Preservation-Phase 2 (NCT NCT01274520)
NCT ID: NCT01274520
Last Updated: 2020-07-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Post-Operative Day 1 to Day 365
Results posted on
2020-07-27
Participant Flow
24 liver recipients who received extended criteria donor (ECD) liver transplant allografts were recruited for our treatment group over a span of 2 years. As a high-volume, major NY transplant center with approximately 270 adult patients on our Liver Transplant Waiting List and 45-50% receiving ECD grafts, we were able to meet our enrollment goal.
Participant milestones
| Measure |
Matched Control Group
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Medtronic Portable Bypass System Group
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypothermic Machine Preservation-Phase 2
Baseline characteristics by cohort
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended criteria donor (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model for End-Stage Liver Disease (MELD) score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-21 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
22-29 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1 to Day 365Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Patient Survival at One Year Post-Transplantation
|
19 participants
|
19 participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1 to Day 365Analysis was based on the amount of liver allografts in each cohort that were deemed to be clinically functional at 1 year post-transplantation (i.e. no re-transplantation required).
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Graft Survival at One Year Post-Transplantation
|
23 grafts
|
23 grafts
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 7Incidence of Primary Graft Nonfunction (PNF), defined as follows: * Relisted for orthotopic liver transplantation (OLT) within 7 days of OLT, not for vascular thromboses * Alanine aminotransferase (ALT) \>2000 and one or both of: acidosis with pH \<7.3 or lactate \>2X (two times) normal * International normalized ratio (INR) \>2.5
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Primary Graft Nonfunction
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Within the first 7 days post-transplantationIncidence of Early Allograft Dysfunction (EAD), defined as follows: * Bilirubin \>10 on post-operative day (POD)#7 * International normalized ratio (INR) \>1.6 on POD#7 * Transaminase level (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) \>2000 within the first 7 days
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Early Allograft Dysfunction (EAD)
|
9 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 1 Month Post-TransplantationIncidence of Retransplants or Hepatic Artery Thrombosis (HAT) within 1 month post-transplantation
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Post-Operative Complications
Retransplant
|
0 participants
|
1 participants
|
|
Incidence of Post-Operative Complications
HAT
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Incidence of bile leaks.
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Bile Leaks
|
3 events
|
0 events
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Incidence of patients who required re-operation for a bleeding event
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Re-Operation For Bleeding
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Hernia Events Within 1 Year Post-Transplantation
|
2 hernia events
|
4 hernia events
|
SECONDARY outcome
Timeframe: First admission after transplantLength of transplant hospital stay post-transplantation (Index Transplant Hospitalization)
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Hospital Length of Stay (Index Transplant Hospitalization)
|
16.5 days
Interval 7.0 to 52.0
|
10 days
Interval 6.0 to 51.0
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Measure of biliary complications as evidenced by mean time with stent (in days).
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Time With Stent (Days)
|
86 days
Interval 14.0 to 365.0
|
66.5 days
Interval 54.0 to 79.0
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Incidence of biliary strictures.
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Biliary Strictures
|
10 events
|
2 events
|
SECONDARY outcome
Timeframe: Post-Operative Day 1 to Day 365Incidence of endoscopic retrograde cholangiopancreatographies (ERCPs)
Outcome measures
| Measure |
Matched Control Group
n=25 Participants
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group
n=24 Participants
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Incidence of Endoscopic Retrograde Cholangiopancreatographies (ERCPs)
|
35 events
|
7 events
|
Adverse Events
Matched Control Group
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Hypothermic Machine Perfusion Group Group
Serious events: 6 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Matched Control Group
n=25 participants at risk
This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.
|
Experimental: Hypothermic Machine Perfusion Group Group
n=24 participants at risk
24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.
|
|---|---|---|
|
Hepatobiliary disorders
Events Requiring Hospitalization
|
44.0%
11/25 • Number of events 11 • 1 year
Serious Adverse Event (SAE) is defined as any clinically significant event which required a hospitalization admission during the subject's participation in the trial. Only SAEs were reported for the purposes of data collection and data analysis in this study.
|
25.0%
6/24 • Number of events 6 • 1 year
Serious Adverse Event (SAE) is defined as any clinically significant event which required a hospitalization admission during the subject's participation in the trial. Only SAEs were reported for the purposes of data collection and data analysis in this study.
|
Other adverse events
Adverse event data not reported
Additional Information
James V. Guarrera, MD, FACS
Columbia University College of Physicians and Surgeons - Center for Liver Disease and Transplantation
Phone: (212)305.3839
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place