Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

Study Overview
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Brief Summary
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The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).

Detailed Description
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Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.

Official Title
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Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients：A Randomized Controlled Trial

Conditions
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Liver Cirrhosis, Portal Vein Thrombosis

Intervention / Treatment
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* Drug: Nadroparin calcium, warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography Exclusion Criteria: Cavernous transformation of the portal vein Uncontrolled active bleeding Platelet count lower than 10*10^9/L Creatinine more than 170 mmol/L Ongoing or received antithrombotic/thrombolytic treatment Primary thrombophilia Budd-Chiari syndrome Pregnancy or breast-feeding period Severe cardiopulmonary diseases Severe systemic infection or sepsis Inability to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nadroparin calcium-warfarin sequential therapy group<br>nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months | Drug: Nadroparin calcium, warfarin<br>* Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.<br>* Other names: Experimental group;|
| No Intervention: Control group<br>No anticoagulation therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recanalization Rate | For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Bleeding | Risk of bleeding episodes | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal vein thrombosis, Nadroparin calcium, Warfarin, Anticoagulation