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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02526303
Recruitment Status : Withdrawn
First Posted : August 18, 2015
Last Update Posted : February 15, 2017
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Portal Vein Thrombosis Anticoagulation Drug: Nadroparin Calcium and Warfarin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis: a Single Center Prospective Randomized Controlled Trial
Actual Primary Completion Date : February 2017

Arm Intervention/treatment
Experimental: 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.
Drug: Nadroparin Calcium and Warfarin
Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year

No Intervention: Non-anticoaglated
No anticoagulatoin or other treatment for PVT will be used in this group of patients.

Primary Outcome Measures :
  1. Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Number of Participants With Liver Decompensation as Assessed by Cummulative Rate [ Time Frame: 2 ]
  2. Number of Participants Who Show Improvement in Child-Pugh score > 2 Points [ Time Frame: 2 years ]
    Child-Pugh Scores range from 5 to 15

  3. Number of Participants Who Show Improvement in MELD Score > 5 points [ Time Frame: 2 year ]
  4. Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography [ Time Frame: 2 years ]
  5. Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate [ Time Frame: 2 years ]
  6. Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate [ Time Frame: 2 years ]
  7. Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model [ Time Frame: 2 years ]
  8. Number of Participants With Major Bleeding as Assessed by Cummulative Rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02526303

Sponsors and Collaborators
Fourth Military Medical University
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Principal Investigator: Guohong Han, PhD,MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University

Additional Information:
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Responsible Party: Guohong Han, Professor, Fourth Military Medical University Identifier: NCT02526303    
Other Study ID Numbers: PVT-AT-1
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Liver Cirrhosis
Venous Thrombosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action