The Effect of Rifaximin on Portal Vein Thrombosis

Cirrhosis Clinical Trial

— ERPVT  

Official title:

The Effect of Rifaximin on Portal Vein Thrombosis in Cirrhotic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03631147
• Other study ID #: CSY-RFXM-PVT
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaoquan HUANG, M.D.
• Phone: 008618801733835
• Email: huangxiaoquan1010[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Rifaximin
400mg bid for 8 weeks

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. Review. — View Citation

Cruz-Ramón V, Chinchilla-López P, Ramírez-Pérez O, Aguilar-Olivos NE, Alva-López LF, Fajardo-Ordoñez E, Ponciano-Rodríguez G, Northup PG, Intagliata N, Caldwell SH, Qi X, Méndez-Sánchez 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. — View 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. — View Citation

Kimer N, Pedersen JS, Tavenier J, Christensen JE, Busk TM, Hobolth L, Krag A, Al-Soud WA, Mortensen MS, Sørensen SJ, Møller 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	8 weeks
Secondary	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)	6 months
Secondary	All clinical events	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death	8 weeks
Secondary	All clinical events	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death	6 months