跳至主要内容
临床试验/NCT00635310
NCT00635310Unknown不适用

Safety Profiles of Percutaneous Liver Biopsy in Hemodialysis Patients With Chronic Hepatitis C Pre-treated With 1-Deamino-8- D-Arginine Vasopressin

National Taiwan University Hospital7 个研究点 分布在 1 个国家目标入组 3,520 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,520
试验地点
7
主要终点
Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis

研究概览

简要总结

Percutaneous liver biopsy (PLB) is the gold standard for grading necroinflammation and staging fibrosis in patients with chronic viral hepatitis. Whether the use of 1-deamino-8-D-arginine vasopressin (DDAVP) before PLBs in hemodialysis (HD) patients with chronic viral hepatitis has comparable safety profiles to those with normal renal function (NRF) has not been evaluated in prospective studies.

详细描述

Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. Currently, percutaneous liver biopsy (PLB) remains the gold standard for grading necroinflammation and staging fibrosis in patients with liver diseases. In addition, liver histology can help clinicians determine the eligibility of renal transplantation, prognosis, and necessity of antiviral therapy in dialysis patients with chronic viral hepatitis. In chronic hepatitis patients with normal renal function (NRF), the risks of fatal and non-fatal hemorrhage after liver biopsies for non-malignant diseases were 0.04% and 0.16%, respectively. However, the relative risks of post-biopsy hemorrhage in CHC patients with end-stage renal disease to those with NRF remain disputed.

Deamino-8-D-arginine vasopressin (DDAVP), a synthetic analogue of vasopressin, is a commonly used hemostatic agent to treat uremic bleeding by inducing the release of von Willebrand factor (vWF) and factor VIII from their storage sites in endothelial cells.Previous studies have shown that one dose of 0.3-0.4μg/kg body weight DDAVP infusion for dialysis patients could normalize bleeding time (BT), and prevent surgical and renal biopsy bleeding. Nevertheless, two recent studies showed divergent liver biopsy-related bleeding complication rates (0% and 6%, respectively) in dialysis CHC patients pre-treated with DDAVP. Since most studies evaluating the safety of PLB in CHC patients with dialysis were small and retrospective in nature, and not controlled by the biopsy route, the type of biopsy needle, the use of ultrasound guidance, or the number of passes,further studies are urgently needed to solve this important issue. Thus, we aimed to conducted a large clinical trial to compare the safety profiles of PLB between CHC patients with hemodialysis (HD) who were pretreated with DDAVP and those with NRF by the same biopsy technique.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Chronic hepatitis C (presence of anti-HCV and serum HCV RNA > 6 months)
  • Chronic hepatitis B (presence of HBsAg > 6 months)
  • Receiving regular hemodialysis or normal renal function (Creatinine < 1.5 x ULN)
  • Receiving percutaneous liver biopsy (PLB)

排除标准

  • Human immunodeficiency virus (HIV) co-infection
  • Unwilling or contraindicated to receive percutaneous liver biopsy (PLB)
  • Receiving liver biopsy without ultrasound (US) guidance or automatic cutting needles
  • Did not receive 2 passes of liver biopsy
  • Inadequate record of post-biopsy complications

结局指标

主要结局

Biopsy-related serious hemorrhage rate by intention-to-treat (ITT) analysis

时间窗: 14 days

次要结局

  • Biopsy-related serious hemorrhage rate by per-protocol (PP) analysis(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验