A Randomized Clinical Study of Retrograde Caval or Antegrade Portal Reperfusion for Early Graft Dysfunction Prevention in Deceased Brain Dead Donor Liver Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence and severity of early graft dysfunction (EAD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •live donor liver transplant
- •reduced and split grafts;
- •multi organ failure (including fulminant and UNOS status 1);
- •fulminant hepatic failure
研究组 & 干预措施
Retrograde reperfusion
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.
干预措施: Retrogade reperfusion (Procedure)
Antegrade reperfusion
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.
干预措施: Antegrade reperfusion (Procedure)
结局指标
主要结局
Incidence and severity of early graft dysfunction (EAD)
时间窗: 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.
次要结局
- Median aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels(24 and 48 hours post reperfusion)
- Incidence of biliary strictures (anastomotic and nonanastomotic)(90 days after liver transplant procedure)
- Incidence of in-hospital mortality(90 days after liver transplant procedure)