Clinical trial NCT03631147: The Effect of Rifaximin on Portal Vein Thrombosis
Official title: The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Portal Vein Thrombosis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes of portal vein thrombosis
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of portal vein thrombosis
timeFrame: 6 months
measure: All clinical events
timeFrame: 8 weeks
measure: All clinical events
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.