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The Effect of Rifaximin on Portal Vein Thrombosis (ERPVT)

Primary Purpose

Cirrhosis, Portal Vein Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 y.o. ≤age≤75 y.o
  • Cirrhotic patients had CTA confirmed portal vein trombosis
  • D-dimer no more than five times the normal upper limit

Exclusion Criteria:

  • age <18 y.o. or age > 75 y.o.
  • had portal cavernoma
  • received anticoagulation treatment in the past 6 months
  • splenectomy
  • Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
  • Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.
  • Acute variceal bleeding within 5 days.
  • Use of other antibiotics in the past 2 weeks
  • Acute portal vein thrombosis

Sites / Locations

  • 180 Fenglin Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rifaximin treatment group

The control group

Arm Description

Rifaximin 400mg bid for 8 weeks

Outcomes

Primary Outcome Measures

Changes of portal vein thrombosis
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)

Secondary Outcome Measures

Changes of portal vein thrombosis
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death
All clinical events
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death

Full Information

First Posted
August 12, 2018
Last Updated
August 12, 2018
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03631147
Brief Title
The Effect of Rifaximin on Portal Vein Thrombosis
Acronym
ERPVT
Official Title
The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 3, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients
Detailed Description
Portal vein thrombosis is not an uncommon complication in cirrhotic portal hypertension, which lead to a poor prognosis in endoscopic management of variceal bleeding. Evidence indicated that enoxaparin prevented PVT and liver decompensation via decreased rates of bacterial infections and lowered the potent inflammatory mediators such as interleukin-6. Rifaximin is a broad-spectrum antibiotic that exerts endotoxin-lowering and anti-inflammatory effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Vein Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin treatment group
Arm Type
Experimental
Arm Description
Rifaximin 400mg bid for 8 weeks
Arm Title
The control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
XIFAXAN
Intervention Description
400mg bid for 8 weeks
Primary Outcome Measure Information:
Title
Changes of portal vein thrombosis
Description
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes of portal vein thrombosis
Description
The changes of portal vein thrombosis in 8 weeks (include main portal vein, left and/or right portal vein, superior mesenteric vein, et al)
Time Frame
6 months
Title
All clinical events
Description
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death
Time Frame
8 weeks
Title
All clinical events
Description
All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 y.o. ≤age≤75 y.o Cirrhotic patients had CTA confirmed portal vein trombosis D-dimer no more than five times the normal upper limit Exclusion Criteria: age <18 y.o. or age > 75 y.o. had portal cavernoma received anticoagulation treatment in the past 6 months splenectomy Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics. Acute variceal bleeding within 5 days. Use of other antibiotics in the past 2 weeks Acute portal vein thrombosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoquan HUANG, M.D.
Phone
008618801733835
Email
huangxiaoquan1010@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao CHEN, M.D.& Ph.D
Email
chen.shiyao@zs-hospital.sh.cn
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24686266
Citation
Qi X, Han G, Fan D. Management of portal vein thrombosis in liver cirrhosis. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):435-46. doi: 10.1038/nrgastro.2014.36. Epub 2014 Apr 1.
Results Reference
background
PubMed Identifier
29720857
Citation
Mantaka A, Augoustaki A, Kouroumalis EA, Samonakis DN. Portal vein thrombosis in cirrhosis: diagnosis, natural history, and therapeutic challenges. Ann Gastroenterol. 2018 May-Jun;31(3):315-329. doi: 10.20524/aog.2018.0245. Epub 2018 Mar 3.
Results Reference
background
PubMed Identifier
21216538
Citation
Qi X, Bai M, Yang Z, Yuan S, Zhang C, Han G, Fan D. Occlusive portal vein thrombosis as a new marker of decompensated cirrhosis. Med Hypotheses. 2011 Apr;76(4):522-6. doi: 10.1016/j.mehy.2010.12.007. Epub 2011 Jan 8.
Results Reference
background
PubMed Identifier
12939586
Citation
D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
Results Reference
background
PubMed Identifier
29735798
Citation
Cruz-Ramon V, Chinchilla-Lopez P, Ramirez-Perez O, Aguilar-Olivos NE, Alva-Lopez LF, Fajardo-Ordonez E, Ponciano-Rodriguez G, Northup PG, Intagliata N, Caldwell SH, Qi X, Mendez-Sanchez N. Thrombosis of the Portal Venous System in Cirrhotic vs. Non-Cirrhotic Patients. Ann Hepatol. 2018 May-June;17(3):476-481. doi: 10.5604/01.3001.0011.7392. Epub 2018 Apr 9.
Results Reference
background
PubMed Identifier
28671712
Citation
Kimer N, Pedersen JS, Tavenier J, Christensen JE, Busk TM, Hobolth L, Krag A, Al-Soud WA, Mortensen MS, Sorensen SJ, Moller S, Bendtsen F; members of the CoRif study group. Rifaximin has minor effects on bacterial composition, inflammation, and bacterial translocation in cirrhosis: A randomized trial. J Gastroenterol Hepatol. 2018 Jan;33(1):307-314. doi: 10.1111/jgh.13852.
Results Reference
background
PubMed Identifier
26618922
Citation
Bajaj JS. Review article: potential mechanisms of action of rifaximin in the management of hepatic encephalopathy and other complications of cirrhosis. Aliment Pharmacol Ther. 2016 Jan;43 Suppl 1:11-26. doi: 10.1111/apt.13435.
Results Reference
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The Effect of Rifaximin on Portal Vein Thrombosis

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