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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
NCT02423941 |
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Date of registration:
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19/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation
REDLIT |
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Scientific title:
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A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02423941 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Belarus
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Contacts
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Name:
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Oleg O Rummo, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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RSPC for organ and tissue transplantation, Minsk 9th clinic |
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Name:
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Aliaksei E Shcherba, PhD |
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Address:
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Telephone:
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+375293330689 |
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Email:
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aleina@tut.by |
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Affiliation:
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Name:
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Aliaksei E Shcherba, PhD |
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Address:
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Telephone:
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+375293330689 |
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Email:
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aleina@tut.by |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
69 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Transplantation
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Reperfusion
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Delayed Graft Function
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Intervention(s)
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Procedure: Antegrade reperfusion
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Procedure: Retrogade reperfusion
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Primary Outcome(s)
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Incidence and severity of early graft dysfunction (EAD)
[Time Frame: 1-7 postoperative days]
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Secondary Outcome(s)
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Incidence of biliary strictures (anastomotic and nonanastomotic)
[Time Frame: 90 days after liver transplant procedure]
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Incidence of in-hospital mortality
[Time Frame: 90 days after liver transplant procedure]
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Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels
[Time Frame: 24 and 48 hours post reperfusion]
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Secondary ID(s)
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616.36-089.843-008.6-07-037
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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