Liver TransplantationPILOT™NCT03484455
Study to Evaluate Performance of the Organ Recovery Systems LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant
A study testing Hypothermic machine perfusion and Static cold storage in people with Liver Transplantation, run by Organ Recovery Systems, Inc. at 9 sites in United States.
Trial summary
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Hypothermic machine perfusion and Static cold storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Apr 2019to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- De novo liver transplant recipient
- Written informed consent required
Who cannot join
- Subject is a multi-organ transplant recipient
- Subject is antibodies blood group (ABO) liver incompatible
- Subject has severe systemic infection
- Subject is Human Immunodeficiency Virus (HIV) positive
- Subject has acute/fulminant liver failure
- Subject is pregnant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Virginia Hospital
Charlottesville, Virginia, 22903
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Intermountain Medical Center
Murray, Utah, 84107
Columbia University Medical Center
New York, New York, 10032
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
University of Rochester Strong Memorial Hospital
Rochester, New York, 14642
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Read the detailed description
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
- Conditions
- Liver Transplantation
- Being tested
- Hypothermic machine perfusion, Static cold storage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic machine perfusionDevice
Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
Static cold storageDevice
Static cold storage (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Hypothermic Machine Perfusion with Organ Recovery Systems LLT system Receives: Device: Hypothermic machine perfusion |
| Static Cold Storage | Active comparator | Standard of Care - Static Cold Storage Receives: Device: Static cold storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in each arm with Early Allograft Dysfunction (EAD)
EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start3 Apr 2019
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ Recovery Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stan Harris, Study director, Organ Recovery SystemsMatthew Copithorne, Study chair, Organ Recovery Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484455
- Sponsor's protocol ID
- 2017-US-01-ORS
- Acronym
- PILOT™
- Status last verified
- Oct 2022
- First submitted
- 2 Mar 2018
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multi-Center Study of the Use of the Organ Recovery Systems LifePort® Liver Transporter (LLT) System With Vasosol® as Compared to Static Cold Storage in Orthotopic Liver Transplants (Perfusion to Improve Liver Outcomes in Transplantation)
- ClinicalTrials.gov ID
- NCT03484455
- Acronym / sponsor ID
- PILOT™ / 2017-US-01-ORS
- Conditions
- Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Organ Recovery Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of hypothermic machine perfusion of livers to standard of care (static cold storage).
Detailed description
Prospective, randomized, multi-center study to show safe and effective use of whole liver preservation via hypothermic machine perfusion (HMP) as compared to livers preserved by static cold storage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermic Machine Perfusion | Experimental | Device: Hypothermic machine perfusionHypothermic Machine Perfusion with Organ Recovery Systems LLT system |
| Static Cold Storage | Active comparator | Device: Static cold storageStandard of Care - Static Cold Storage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Active on the United Network for Organ Sharing (UNOS) waiting list for liver transplantation
- De novo liver transplant recipient
- Written informed consent required
Key exclusion criteria (6 listed)
- Subject is a multi-organ transplant recipient
- Subject is antibodies blood group (ABO) liver incompatible
- Subject has severe systemic infection
- Subject is Human Immunodeficiency Virus (HIV) positive
- Subject has acute/fulminant liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic machine perfusionOrgan Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution | Device | Hypothermic Machine Perfusion |
| Static cold storageStatic cold storage (standard of care) | Device | Static Cold Storage |
Primary outcome
Number of patients in each arm with Early Allograft Dysfunction (EAD)
Time frame: 7 days
EAD defined as total bilirubin ≥ 10 mg/dL or International Normalized Ratio (INR) ≥ 1.6 or Aspartate Aminotransferase (AST) >2000IU/L or Alanine Aminotransferase (ALT) > 2000 IU/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Liver Transplantation
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stan Harris study director
Organ Recovery Systems
Matthew Copithorne study chair
Organ Recovery Systems
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic machine perfusion and Static cold storage in people with Liver Transplantation, run by Organ Recovery Systems, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in each arm with Early Allograft Dysfunction (EAD) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.