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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.
 
ClinicalTrials.gov Identifier: NCT02526303
Recruitment Status : Withdrawn
First Posted : August 18, 2015
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Guohong Han, Fourth Military Medical University

Tracking Information
First Submitted Date  ICMJE August 13, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2015)
Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate [ Time Frame: 2 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02526303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2015)
  • Number of Participants With Liver Decompensation as Assessed by Cummulative Rate [ Time Frame: 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
  • Number of Participants Who Show Improvement in MELD Score > 5 points [ Time Frame: 2 year ]
  • Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography [ Time Frame: 2 years ]
  • Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate [ Time Frame: 2 years ]
  • Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate [ Time Frame: 2 years ]
  • Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model [ Time Frame: 2 years ]
  • Number of Participants With Major Bleeding as Assessed by Cummulative Rate [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis
Official Title  ICMJE Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis: a Single Center Prospective Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Cirrhosis
  • Portal Vein Thrombosis
  • Anticoagulation
Intervention  ICMJE Drug: Nadroparin Calcium and Warfarin
Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Nadroparin Calcium and Warfarin
  • No Intervention: Non-anticoaglated
    No anticoagulatoin or other treatment for PVT will be used in this group of patients.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 13, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2015)
66
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526303
Other Study ID Numbers  ICMJE PVT-AT-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guohong Han, Fourth Military Medical University
Study Sponsor  ICMJE Fourth Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guohong Han, PhD,MD Xijing Hospital of Digestive Diseases, Fourth Military Medical University
PRS Account Fourth Military Medical University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP