Liver TransplantationREDLITNCT02423941
A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation
A study testing Retrogade reperfusion and Antegrade reperfusion in people with Liver Transplantation and Reperfusion, run by Republican Scientific and Practical Center for Organ and Tissue Transplantation at 1 site in Belarus.
Trial summary
To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction. All eligible enrolled liver transplant candidates will be randomized to receive either: 1. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Liver Transplantation, Reperfusion, Delayed Graft Function
- What is being tested?
- Retrogade reperfusion and Antegrade reperfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelarus
- Study dates
- Apr 2015to May 2017
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Donor Inclusion Criteria:
- deceased brain dead
- age 18-59
- length of ICU treatment up to 7 days
- highest AST and ALT up to 200 UI/L
- macroscopic steatosis up to 30%
- highest serum sodium up to 165 mmol/L
- highest bilirubin 25 µmol/L
- application of norepinephrine is allowed
- preservation solution - HTK (Custodiol)
Recipient inclusion Criteria:
- age 18-69
- primary liver transplant
- full-size transplant
Technique of liver transplant:
- with IVC resection;
- without veno-venous bypass;
- sequential portal-arterial reperfusion
- flushing of portal vascular bed with 500 ml of called to 2-4 °C saline at back-table before implantataion
Recipient exclusion Criteria:
- live donor liver transplant
- reduced and split grafts;
- multi organ failure (including fulminant and UNOS status 1);
- fulminant hepatic failure
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
RSPC for organ and tissue transplantation, Minsk 9th clinic
Minsk, 220116
Aliaksei E Shcherba, PhD, +375293330689, aleina@tut.by
Denis F Efimov, +375(29)6884415, den.efimoff@gmail.com
About this study
Official title: A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation
To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.
All eligible enrolled liver transplant candidates will be randomized to receive either:
- retrograde caval, followed by sequential portal-arterial, reperfusion or
- antegrade, sequential portal-arterial reperfusion.
Read the detailed description
We hypothesize that retrograde caval reperfusion could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.
Chi-square method of sample size estimation with a=0,05, b=0,20 and P1-P2 = 0,25 required a 41 subject per group (Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams \& Wilkins, 2013).
After signing the informed consent 90 patients will be randomized to study and active-control group (45 each).
Only patients undergoing classical technique (retrohepatic IVC resection) of liver transplantation without vena-venous bypass will be enrolled to the study.
In the study group after completion of both caval anastomoses (super and infra-hepatic) the infra-hepatic cava-clamp is released and removed allowing the filling and flushing the liver retrogradely through the hepatic veins. 300 ml of blood is drained via donor portal vein and the vein will be clamped.
Suprahepatic cava-clamp is released and removed allowing venous return to the right atrium.
Portal vein anastomosis will be constructed. Before the last 2-3 stitches another 100 ml will be drained retrogradely. Recipient portal vein clamp is removed and liver will be reperfused antegradely. After that arterial and biliary anastomoses will be constructed.
In the control group cava-clamps are not removed until completion the portal vein anastomosis.
Chi-square test and regression analysis will be used to test the difference in incidence of early allograft liver dysfunction in the study groups.
Mann-Whitney test will be used to compare the median of highest aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 24 and 48 hours post-reperfusion.
- Conditions
- Liver Transplantation, Reperfusion, Delayed Graft Function
- Being tested
- Retrogade reperfusion, Antegrade reperfusion
- Keywords
- Liver Transplantation, Retrograde Reperfusion, Graft dysfunction, Randomized study
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrogade reperfusionProcedure or surgery
Also called Caval reperfusion
Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
Antegrade reperfusionProcedure or surgery
Also called Conventional sequential portal-arterial reperfusion
Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Retrograde reperfusion | Experimental | During the transplant procedure the liver is initially reperfused retrogradely via hepatic veins. Venting of 300 ml blood is allowed via donor portal vein. After completion the portal vein anastomosis and retrograde venting of another 100 ml blood the antegrade portal reperfusion is performed. Receives: Procedure: Retrogade reperfusion |
| Antegrade reperfusion | Active comparator | During the transplant procedure the liver is reperfused conventionally, antegradely via portal vein after completion of caval and portal anastomoses. Venting of 300 ml blood is allowed via tube placed in infrahepatiс caval anastomosis before unclamping the vena cava. Receives: Procedure: Antegrade reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of early graft dysfunction (EAD)
EAD will be assessed according to Olthoff KM, et al. Liver Transpl. 2010. Severe EAD will be assessed according to P.R. Salvalaggio, et al. Transplantation Proceedings, 2012.
Measured: 1-7 postoperative days
Secondary outcomes (3)
Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Measured: 24 and 48 hours post reperfusion
Incidence of biliary strictures (anastomotic and nonanastomotic)
All biliary strictures would be diagnosed by cholangiography, either ERCP or MRCP. Ulrtrasound will be used as a screening tool to assign a cholestatic patient to cholangiography.
Measured: 90 days after liver transplant procedure
Incidence of in-hospital mortality
Measured: 90 days after liver transplant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Republican Scientific and Practical Center for Organ and Tissue Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oleg O Rummo, MD PhD, Study chair, RSPC for organ and tissue transplantation, Minsk 9th clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423941
- Sponsor's protocol ID
- 616.36-089.843-008.6-07-037
- Acronym
- REDLIT
- Status last verified
- Dec 2016
- First submitted
- 19 Apr 2015
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
PubMed 20677285Salvalaggio P, Afonso RC, Felga G, Ferraz-Neto BH. A proposal to grade the severity of early allograft dysfunction after liver transplantation. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):23-31. doi: 10.1590/s1679-45082013000100006.
PubMed 23579740Designing Clinical Research/Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013.-367p.]
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT02423941
- Acronym / sponsor ID
- REDLIT / 616.36-089.843-008.6-07-037
- Conditions
- Liver Transplantation, Reperfusion, Delayed Graft Function
- Keywords
- Liver Transplantation, Retrograde Reperfusion, Graft dysfunction, Randomized study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Republican Scientific and Practical Center for Organ and Tissue TransplantationUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 22 Apr 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.
To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.
All eligible enrolled liver transplant candidates will be randomized to receive either:
- retrograde caval, followed by sequential portal-arterial, reperfusion or
- antegrade, sequential portal-arterial reperfusion.
Detailed description
We hypothesize that retrograde caval reperfusion could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.
Chi-square method of sample size estimation with a=0,05, b=0,20 and P1-P2 = 0,25 required a 41 subject per group (Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams \& Wilkins, 2013).
After signing the informed consent 90 patients will be randomized to study and active-control group (45 each).
Only patients undergoing classical technique (retrohepatic IVC resection) of liver transplantation without vena-venous bypass will be enrolled to the study.
In the study group after completion of both caval anastomoses (super and infra-hepatic) the infra-hepatic cava-clamp is released and removed allowing the filling and flushing the liver retrogradely through the hepatic veins. 300 ml of blood is drained via donor portal vein and the vein will be clamped.
Suprahepatic cava-clamp is released and removed allowing venous return to the right atrium.
Portal vein anastomosis will be constructed. Before the last 2-3 stitches another 100 ml will be drained retrogradely. Recipient portal vein clamp is removed and liver will be reperfused antegradely. After that arterial and biliary anastomoses will be constructed.
In the control group cava-clamps are not removed until completion the portal vein anastomosis.
Chi-square test and regression analysis will be used to test the difference in incidence of early allograft liver dysfunction in the study groups.
Mann-Whitney test will be used to compare the median of highest aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 24 and 48 hours post-reperfusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrograde reperfusion | Experimental | Procedure: Retrogade reperfusionDuring the transplant procedure the liver is initially reperfused retrogradely via hepatic veins. Venting of 300 ml blood is allowed via donor portal vein. After completion the portal vein anastomosis and retrograde venting of another 100 ml blood the antegrade portal reperfusion is performed. |
| Antegrade reperfusion | Active comparator | Procedure: Antegrade reperfusionDuring the transplant procedure the liver is reperfused conventionally, antegradely via portal vein after completion of caval and portal anastomoses. Venting of 300 ml blood is allowed via tube placed in infrahepatiс caval anastomosis before unclamping the vena cava. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Retrogade reperfusionAlso: Caval reperfusionRetrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion. | Procedure or surgery | Retrograde reperfusion |
| Antegrade reperfusionAlso: Conventional sequential portal-arterial reperfusionAntegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion. | Procedure or surgery | Antegrade reperfusion |
Primary outcome
Incidence and severity of early graft dysfunction (EAD)
Time frame: 1-7 postoperative days
EAD will be assessed according to Olthoff KM, et al. Liver Transpl. 2010. Severe EAD will be assessed according to P.R. Salvalaggio, et al. Transplantation Proceedings, 2012.
3 secondary outcomes
Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
Time frame: 24 and 48 hours post reperfusion
Incidence of biliary strictures (anastomotic and nonanastomotic)
Time frame: 90 days after liver transplant procedure
Incidence of in-hospital mortality
Time frame: 90 days after liver transplant procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Background: PubMed 20677285Olthoff KM, Kulik L, Samstein B, Kaminski M, Abecassis M, Emond J, Shaked A, Christie JD. Validation of a current definition of early allograft dysfunction in liver transplant recipients and analysis of risk factors. Liver Transpl. 2010 Aug;16(8):943-9. doi: 10.1002/lt.22091.
- Background: PubMed 23579740Salvalaggio P, Afonso RC, Felga G, Ferraz-Neto BH. A proposal to grade the severity of early allograft dysfunction after liver transplantation. Einstein (Sao Paulo). 2013 Jan-Mar;11(1):23-31. doi: 10.1590/s1679-45082013000100006.
- BackgroundDesigning Clinical Research/Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013.-367p.]
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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.
Oleg O Rummo, MD PhD study chair
RSPC for organ and tissue transplantation, Minsk 9th clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrogade reperfusion and Antegrade reperfusion in people with Liver Transplantation and Reperfusion, run by Republican Scientific and Practical Center for Organ and Tissue Transplantation at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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 Belarus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaksei E Shcherba, PhD (+375293330689, aleina@tut.by), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of early graft dysfunction (EAD) (time frame: 1-7 postoperative days). 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 NCT02423941, which also lists 3 linked publications.
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 4 Jan 2017.