Clinical trial NCT02526303: Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis
Official title: Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis: a Single Center Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Cirrhosis
Portal Vein Thrombosis
Anticoagulation
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate
timeFrame: 2 year
Secondary outcomes:
measure: Number of Participants With Liver Decompensation as Assessed by Cummulative Rate
timeFrame: 2
measure: Number of Participants Who Show Improvement in Child-Pugh score > 2 Points
timeFrame: 2 years
measure: Number of Participants Who Show Improvement in MELD Score > 5 points
timeFrame: 2 year
measure: Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography
timeFrame: 2 years
measure: Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate
timeFrame: 2 years
measure: Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate
timeFrame: 2 years
measure: Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model
timeFrame: 2 years
measure: Number of Participants With Major Bleeding as Assessed by Cummulative Rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
name: Guohong Han, PhD,MD
role: PRINCIPAL_INVESTIGATOR
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: 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.