Hepatocellular InjuryPERPHONCT03376074
Interest of Oxygenated Hypothermic Perfusion (PHO) in Preservation of Hepatic Grafts From Expanded Criteria Donors
A study testing Hypothermic oxygenated perfusion (HOPE) and Conventional cold storage in people with Hepatocellular Injury, run by Rennes University Hospital at 1 site in France.
Trial summary
Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Hepatocellular Injury
- What is being tested?
- Hypothermic oxygenated perfusion (HOPE) and Conventional cold storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2018to 7 Feb 2019
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
- With cirrhosis whatever its etiology and gravity
- With or without hepatocarcinoma
- Having given free, informed and written consent
- LT made from a whole graft, harvested from a brain-dead donor with ECD criteria, defined as the presence of at least one of the following criteria:
Show all 14Show fewer
- Age> 65 years
- BMI> 30 kg / m2
- Duration of hospitalization in intensive care unit> 7 days
- Natremia> 155 mmol / l
- AST> 150 IU / ml
- ALT> 170 IU / ml
- Occurrence of cardiac arrest before harvesting
- Macrovacuolar steatosis> 30% on liver histology
Who cannot join
- History of organ transplantation
- Transplantation in emergency
- Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
- Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.
Read the detailed description
The excellent results of liver transplantation (LT) have led to a significant increase in the number of patients awaiting transplantation. At the same time, the number of grafts remains stable. To extend the donor pool, the use of Extended Criteria Donor (ECD) donors graft increased each year despite the fact that these graft are known to be more vulnerable to ischemia-reperfusion injuries induced by cold storage preservation (CS). Their use is therefore associated with a greater risk of postoperative dysfunction of the graft. This risk can be reduced by improving preservation quality.
The preservation by hypothermic oxygenated perfusion (HOPE) consists of keeping the graft in hypothermia (4 to 12 °C) on an machine perfusion (MP) using a specific solution, saturated with oxygen. In kidney transplantation, the use of MP has been shown to improve graft function as well as graft survival, especially for ECD grafts.
In liver transplantation, experimental studies on animal models have demonstrated the superiority of HOPE over CS regarding graft function and survival. These results have been confirmed in humans on small retrospective series.
As HOPE is an expensive procedure, obtaining evidence of its effectiveness could result in a reimbursement of the additional cost.
- Conditions
- Hepatocellular Injury
- Being tested
- Hypothermic oxygenated perfusion (HOPE), Conventional cold storage
- Keywords
- liver transplantation, hypothermic machine liver perfusion, extended criteria liver grafts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic oxygenated perfusion (HOPE)Device
25 patients: Application of HOPE for 2 hours, perfusion rate 100-150 ml/min, pressure controlled, perfusion pressure < 3 mm Hg, perfusion route portal vein, recirculating system, perfusion volume 2 L, perfusate solution (UWMP®), perfusate temperature 4-12 °C, perfusate oxygenation 40 KPa
Conventional cold storageOther
75 patients transplanted in Rennes between 2010 and 2015 with a cold stored grafts, matched (ratio 1: 3) using a propensity score calculated according to some parameters
| Study group | Role | What they receive |
|---|---|---|
| Hypothermic oxygenated perfusion (HOPE) | Experimental | Application of HOPE for 2 hours Receives: Device: Hypothermic oxygenated perfusion (HOPE) |
| Conventional cold storage | Active comparator | Not described Receives: Other: Conventional cold storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
Occurrence of early allograft dysfunction and / or primary non function
Measured: Day 7
Secondary outcomes (8)
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Number of intraoperative transfusions
Measured: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Incidence of reperfusion syndrome defined as a 30 % decrease of mean arterial pressure, for at least 1 minute, during the 5 minutes following revascularization
Measured: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity
Measured: Day 7
Evaluation of graft's survival
Occurrence of a vascular and biliary complication
Measured: Month 3
Number of days of hospitalization (initial stay) after transplantation
Measured: Postoperative course
Number of days of hospitalization after transplantation
Measured: Month 3
Cost of the initial stay
Measured: Postoperative course
Cost of the hospitalization stay
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start19 Feb 2018
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular InjuryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376074
- Sponsor's protocol ID
- 35RC16_9792_PERPHO
- Other IDs
- 2017-A00085-48
- Acronym
- PERPHO
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2017
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rayar M, Beaurepaire JM, Bajeux E, Hamonic S, Renard T, Locher C, Desfourneaux V, Merdrignac A, Bergeat D, Lakehal M, Sulpice L, Houssel-Debry P, Jezequel C, Camus C, Bardou-Jacquet E, Meunier B. Hypothermic Oxygenated Perfusion Improves Extended Criteria Donor Liver Graft Function and Reduces Duration of Hospitalization Without Extra Cost: The PERPHO Study. Liver Transpl. 2021 Feb;27(3):349-362. doi: 10.1002/lt.25955.
PubMed 33237618
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.
- ClinicalTrials.gov ID
- NCT03376074
- Acronym / sponsor ID
- PERPHO / 35RC16_9792_PERPHO
- Conditions
- Hepatocellular Injury
- Keywords
- liver transplantation, hypothermic machine liver perfusion, extended criteria liver grafts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 18 Dec 2017 (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.
Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.
Detailed description
The excellent results of liver transplantation (LT) have led to a significant increase in the number of patients awaiting transplantation. At the same time, the number of grafts remains stable. To extend the donor pool, the use of Extended Criteria Donor (ECD) donors graft increased each year despite the fact that these graft are known to be more vulnerable to ischemia-reperfusion injuries induced by cold storage preservation (CS). Their use is therefore associated with a greater risk of postoperative dysfunction of the graft. This risk can be reduced by improving preservation quality.
The preservation by hypothermic oxygenated perfusion (HOPE) consists of keeping the graft in hypothermia (4 to 12 °C) on an machine perfusion (MP) using a specific solution, saturated with oxygen. In kidney transplantation, the use of MP has been shown to improve graft function as well as graft survival, especially for ECD grafts.
In liver transplantation, experimental studies on animal models have demonstrated the superiority of HOPE over CS regarding graft function and survival. These results have been confirmed in humans on small retrospective series.
As HOPE is an expensive procedure, obtaining evidence of its effectiveness could result in a reimbursement of the additional cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermic oxygenated perfusion (HOPE) | Experimental | Device: Hypothermic oxygenated perfusion (HOPE)Application of HOPE for 2 hours |
| Conventional cold storage | Active comparator | Other: Conventional cold storage |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients older than 18 years
- Candidates for a first orthotopic liver transplantation, without transplantation of another associated organ (kidney, pancreas, heart, lung, intestine)
- With cirrhosis whatever its etiology and gravity
- With or without hepatocarcinoma
- Having given free, informed and written consent
Key exclusion criteria (4 listed)
- History of organ transplantation
- Transplantation in emergency
- Transplantation from a living donor, a reduced graft or a graft from a deceased donor by cardiac arrest (DCD)
- Major persons subject to legal protection (safeguard of justice, guardianship), persons deprived of their liberty
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 oxygenated perfusion (HOPE)25 patients: Application of HOPE for 2 hours, perfusion rate 100-150 ml/min, pressure controlled, perfusion pressure < 3 mm Hg, perfusion route portal vein, recirculating system, perfusion volume 2 L, perfusate solution (UWMP®), perfusate temperature 4-12 °C, perfusate oxygenation 40 KPa | Device | Hypothermic oxygenated perfusion (HOPE) |
| Conventional cold storage75 patients transplanted in Rennes between 2010 and 2015 with a cold stored grafts, matched (ratio 1: 3) using a propensity score calculated according to some parameters | Other | Conventional cold storage |
Primary outcome
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery
Time frame: Day 7
Occurrence of early allograft dysfunction and / or primary non function
8 secondary outcomes
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Time frame: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on intraoperative morbidity
Time frame: Day 1
Evaluation of the impact of PHO during the conservation of ECD liver grafts on postoperative morbidity
Time frame: Day 7
Evaluation of graft's survival
Time frame: Month 3
Number of days of hospitalization (initial stay) after transplantation
Time frame: Postoperative course
Number of days of hospitalization after transplantation
Time frame: Month 3
Cost of the initial stay
Time frame: Postoperative course
Cost of the hospitalization stay
Time frame: Month 3
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 11 Mar 2019.
- Derived from this study: PubMed 33237618Rayar M, Beaurepaire JM, Bajeux E, Hamonic S, Renard T, Locher C, Desfourneaux V, Merdrignac A, Bergeat D, Lakehal M, Sulpice L, Houssel-Debry P, Jezequel C, Camus C, Bardou-Jacquet E, Meunier B. Hypothermic Oxygenated Perfusion Improves Extended Criteria Donor Liver Graft Function and Reduces Duration of Hospitalization Without Extra Cost: The PERPHO Study. Liver Transpl. 2021 Feb;27(3):349-362. doi: 10.1002/lt.25955.
- Individual participant dataSharing planned: No
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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 Hypothermic oxygenated perfusion (HOPE) and Conventional cold storage in people with Hepatocellular Injury, run by Rennes University Hospital at 1 site in France.
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 14 inclusion and 4 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 11 Mar 2019. 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 France. 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?
Evaluation of the performance of HOPE in the preservation of ECD liver grafts on graft function recovery (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376074, which also lists 1 linked publication.
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 11 Mar 2019.