Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis

NCT ID: NCT02526303

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

The purpose of this study is to determine the safety and efficacy of anticoagulation in the treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.

Detailed Description

Portal vein thrombosis is a common complication of liver cirrhosis, especially at the decompensated or advanced stage. The reported prevalence was 10-25% by ultrasound. The effect of PVT on the natural history of liver cirrhosis is not clear, especially the non-occlusive PVT. According to a recent large prospective study (n=1243), the development of PVT and the progression of liver disease are two separate consequences of a common mechanism. It was hypothesized that the activation of coagulation factors in the cirrhotic liver or the portal venous system is the common mechanism for the progression of liver disease, on the one hand, and the development of PVT on the other. A recent randomized clinical trial has shown that enoxaparin therapy for 48 weeks can prevent disease progression and PVT in patients with Child class B-C cirrhosis. Besides, emerging evidences have shown that 30-50% of patients with cirrhosis and partial PVT can achieve this spontaneous recanalization. So what the role of anticoagulation played in the management of PVT in liver cirrhosis is still contraversal. Anticoagulation therapy was also shown very effective with a high recanalization rate of 42-100%. But this data was mostly derived from retrospective, non-randomized study and no well-designed randomized controlled trial has been conducted to evaluate the safety and efficacy of anticoagulation for non-occlusive PVT.

Conditions

Liver Cirrhosis; Portal Vein Thrombosis; Anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anticoagulation

Drug: Nadroparin Calcium and Warfarin Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,along with Nadroparin Calcium 85IU／kg，subcutaneous, q12h,for the first 5 days at least.

Group Type: EXPERIMENTAL

Nadroparin Calcium and Warfarin

Intervention Type: DRUG

Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year

Non-anticoaglated

No anticoagulatoin or other treatment for PVT will be used in this group of patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nadroparin Calcium and Warfarin

Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent was obtained
• liver cirrhosis
• Non-occlusive portal vein thrombosis
• No history of variceal bleeding or receive endoscopy or β-blocker for the prevention of patients with G3 or G2 with red marks within 3 months before enrollment
• No plan for liver transplantation
• Age between 18 and 70
• Child-Pugh score ≤ 11

Exclusion Criteria

• Acute PVT
• Fibrotic cord of PV
• Isolated splenic vein thrombosis or isolated superior mesenteric vein thrombosis
• Extensive superior mesenteric vein thrombosis involving the distal part
• Known coagulation disorder besides liver cirrhosis
• HCC or other malignant tumor
• Patients with G2 varices with red mark or G3 but did not underwent any preventive endoscopy or β-blockers
• Platelet count < 10×109/L
• Receive contraceptive, anticoagulation or antiplatelet drug
• Receiving thrombolysis treatment
• Receiving TIPS or shunting surgery
• Bleeding tendency
• Recent gastrointestinal bleeding like digestive ulcer or hemorrhagic stroke
• Severe portal hypertension，for example, refractory ascite or acute variceal bleeidng
• Spontaneous bacterial peritonitis
• Severe cardiovascular disorder, endocrine disorder, or mental disease
• Major surgery within 6 months
• History of organ transplantation
• Pregnancy or breast-feeding
• History of HIV
• Poor compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Guohong Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guohong Han, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive Diseases, Fourth Military Medical University

References

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)

Nery F, Chevret S, Condat B, de Raucourt E, Boudaoud L, Rautou PE, Plessier A, Roulot D, Chaffaut C, Bourcier V, Trinchet JC, Valla DC; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis: results of a longitudinal study. Hepatology. 2015 Feb;61(2):660-7. doi: 10.1002/hep.27546. Epub 2015 Jan 5.

Reference Type: BACKGROUND

PMID: 25284616 (View on PubMed)

Related Links

http://www.nature.com/nrgastro/journal/v11/n7/full/nrgastro.2014.36.html

Click here for more information about this study:Management of portal vein thrombosis in liver cirrhosis

http://onlinelibrary.wiley.com/doi/10.1002/hep.27546/abstract;jsessionid=4DD964EC32D8C25909D9E484E2F88C48.f01t03

Click here for more information about this study:Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis

Other Identifiers

PVT-AT-1

Identifier Type: -

Identifier Source: org_study_id