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临床试验/NCT03201367
NCT03201367已完成不适用

Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis

Zagazig University0 个研究点目标入组 40 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
complete recanalization of the portal vein

研究概览

简要总结

Portal vein thrombosis (PVT) in patients with liver cirrhosis may be due to neoplastic growth or non-neoplastic causes.

  • Treating PVT with anticoagulation in liver cirrhosis is difficult to be established but may be of great benefit in acute symptomatic PVT.
  • The ultimate goal is complete recanalization of the portal vein without inducing major bleeding, abnormal liver function tests or increased mortality.

详细描述

Out of 220 patients with chronic HCV who had undergone splenectomy due to hypersplenism in the period extending from May 2014 until August 2016; 36 participants (16.4%) were selected. They were presented with acute PVT. Also, the investigators enrolled 4 patients who were presented with PVT due to portal pyemia complicated infected thrombosed internal piles (n=1), appendicular abscess (n=1), ulcerative colitis (n=2).

Control group It included 30 patients who had acute non-neoplastic PVT with the same inclusion criteria and were given symptomatic therapy for ascites, abdominal pain and followed synchronously with the study group.

Laboratory investigations They included investigation preliminary to splenectomy as liver function tests, coagulation profile, renal function tests, complete blood count, reticulocyte count and bone marrow aspiration. For each patient, Child-Pugh (CTP) and MELD scores were calculated.

Abdominal Ultrasonography (USG) Cirrhotic echo pattern, criteria of portal hypertension, ascites, HCC were excluded Color Doppler Sonography to confirm the diagnosis of PVT. Upper GI Endoscopy All the patients before splenectomy were exposed to upper GI endoscopy to detect the presence and grading of gastro-esophageal varices.

Protocol of therapy Enoxaparin was initiated at a dose of 1mg/kg every 12 hours subcutaneously for 3 days then treatment was continued with rivaroxaban 10mg/12 hr. Rivaroxaban was started 2 hours before the next dose of enoxaparin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

open label

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute non-neoplastic portal vein thrombosis
  • Compensated cirrhosis (Child class A-B)
  • The onset of PVT is within 1 week.

排除标准

  • Decompensated liver disease
  • Bleeding tendency or recent bleeding event as bleeding peptic ulcer or oesophageal varices
  • Neoplastic invasion of the portal vein
  • Renal impairment with the creatinine clearance ≤ 30 ml/min
  • Pregnancy and breastfeeding
  • Hypersensitivity to rivaroxaban
  • Concomitant treatment with another anticoagulant
  • Concomitant use of clopidogrel.

研究组 & 干预措施

study group

Active Comparator

acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis

  • treated with rivaroxaban

干预措施: Rivaroxaban (Drug)

control group

Placebo Comparator

acute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis receive placebo

干预措施: symptomatic therapy for ascites, abdominal pain (Other)

结局指标

主要结局

complete recanalization of the portal vein

时间窗: 6 months

bedside ultrasonography for detection of thrombus resolution

次要结局

  • Hepatotoxicity(6 MONTHS)
  • major bleeding(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr Shaaban Hanafy

Assistant professor

Zagazig University

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