Liver Transplantation Clinical Trial
— REDLITOfficial 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:
1. retrograde caval, followed by sequential portal-arterial, reperfusion or
2. antegrade, sequential portal-arterial reperfusion.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | May 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Belarus | RSPC for organ and tissue transplantation, Minsk 9th clinic | Minsk |
Lead Sponsor | Collaborator |
---|---|
Republican Scientific and Practical Center for Organ and Tissue Transplantation |
Belarus,
Designing Clinical Research/Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams & Wilkins, 2013.-367p.]
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. — View Citation
Salvalaggio 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. English, Portuguese. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1-7 postoperative days | No |
Secondary | Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels | 24 and 48 hours post reperfusion | No | |
Secondary | 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. | 90 days after liver transplant procedure | Yes |
Secondary | Incidence of in-hospital mortality | 90 days after liver transplant procedure | No |
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