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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulation | Experimental | 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. |
|
| Non-anticoaglated | No Intervention | No anticoagulatoin or other treatment for PVT will be used in this group of patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin Calcium and Warfarin | Drug | Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Liver Decompensation as Assessed by Cummulative Rate | 2 | |
| Number of Participants Who Show Improvement in Child-Pugh score > 2 Points | Child-Pugh Scores range from 5 to 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guohong Han, PhD,MD | Xijing Hospital of Digestive Diseases, Fourth Military Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24686266 | Background | 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. | |
| 25284616 | Background | 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. |
| Label | URL |
|---|---|
| Click here for more information about this study:Management of portal vein thrombosis in liver cirrhosis | View source |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| 2 years |
| Number of Participants Who Show Improvement in MELD Score > 5 points | 2 year |
| Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography | 2 years |
| Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate | 2 years |
| Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate | 2 years |
| Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model | 2 years |
| Number of Participants With Major Bleeding as Assessed by Cummulative Rate | 2 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |