Liver PreservationREVIVENCT02449694
Trial of the TransMedics Organ Care System™ Liver For Preserving and Assessing Donor Livers for Transplantation
A study testing OCS Liver in people with Liver Preservation, run by TransMedics at 1 site in United Kingdom.
Trial summary
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Preservation
- What is being tested?
- OCS Liver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Jan 2018
- 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
- Registered male or female primary Liver transplant candidate
- Age ≥18 years old
- Signed: written informed consent
Who cannot join
- Acute, fulminant liver failure;
- Prior solid organ or bone marrow transplant;
- Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
- Multi-organ transplant;
- Ventilator dependent;
- Dependent on > 1 IV inotrope to maintain hemodynamics;
- Malignancy excluding HCC;
- Infection.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. James's University Hospital
Leeds, West Yorkshire, LS9 7 TF
About this study
Official title: Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
- Conditions
- Liver Preservation
- Being tested
- OCS Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS LiverDevice
OCS Liver will be used to preserve the donor liver
| Study group | Role | What they receive |
|---|---|---|
| OCS Liver | Experimental | OCS Liver will be used to preserve the donor liver Receives: Device: OCS Liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of donor livers preserved by OCS in a near physiologic state.
Measured: Within 1 day of organ retrieval
Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted
Measured: Within 1 day of organ retrieval
Secondary outcomes (3)
Number of donor livers maintained in a metabolically active and functioning state during preservation.
Measured: Within 1 day of organ retrieval
Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.
Measured: Within 1 day of organ retrieval
Frequency of liver graft-related serious adverse events
Measured: 30 days after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMay 2016
- Primary completion19 Sep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver PreservationStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449694
- Sponsor's protocol ID
- OCS-LVR-022015
- Acronym
- REVIVE
- Status last verified
- Apr 2018
- First submitted
- 11 May 2015
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Prospective Trial to Evaluate The Safety and Performance of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation
- ClinicalTrials.gov ID
- NCT02449694
- Acronym / sponsor ID
- REVIVE / OCS-LVR-022015
- Conditions
- Liver Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 May 2015 (estimated)
- 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.
A prospective, single-center controlled trial to evaluate the safety and performance of the portable Organ Care System (OCS) Liver for preservation and assessment of donor livers for transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Liver | Experimental | Device: OCS LiverOCS Liver will be used to preserve the donor liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered male or female primary Liver transplant candidate
- Age ≥18 years old
- Signed: written informed consent
Key exclusion criteria (8 listed)
- Acute, fulminant liver failure;
- Prior solid organ or bone marrow transplant;
- Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl (>265 mmol/L) for >2 weeks and/or requiring hemodialysis;
- Multi-organ transplant;
- Ventilator dependent;
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 |
|---|---|---|
| OCS LiverOCS Liver will be used to preserve the donor liver | Device | OCS Liver |
Primary outcome
Number of donor livers preserved by OCS in a near physiologic state.
Time frame: Within 1 day of organ retrieval
Number of events directly related to the use of the OCS Liver that led to the donor liver being deemed not clinically acceptable and, as a result, not transplanted
Time frame: Within 1 day of organ retrieval
3 secondary outcomes
Number of donor livers maintained in a metabolically active and functioning state during preservation.
Time frame: Within 1 day of organ retrieval
Number of donor livers monitored for perfusate temperatures, SvO2, hematocrit, Hepatic Artery flow rates, Portal Vein flow rate, Hepatic Artery pressure, Portal vein pressure, and bile production during preservation.
Time frame: Within 1 day of organ retrieval
Frequency of liver graft-related serious adverse events
Time frame: 30 days after transplantation
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 6 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Liver in people with Liver Preservation, run by TransMedics at 1 site in United Kingdom.
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 3 inclusion and 8 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 donor livers preserved by OCS in a near physiologic state. (time frame: Within 1 day of organ retrieval). The study lists 2 primary outcomes in all. 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 6 Apr 2018.