The Effect of Rifaximin on Portal Vein Thrombosis

NCT ID: NCT03631147

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the efficacy of rifaximin in the treatment of portal vein thrombosis in cirrhotic patients

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhosis Portal Vein Thrombosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rifaximin treatment group

Rifaximin 400mg bid for 8 weeks

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

400mg bid for 8 weeks

The control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rifaximin

400mg bid for 8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

XIFAXAN

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shiyao Chen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaoquan HUANG, M.D.

Role: CONTACT

008618801733835

Shiyao CHEN, M.D.& Ph.D

Role: CONTACT

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24686266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29720857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21216538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12939586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29735798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28671712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26618922 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSY-RFXM-PVT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.