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The Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis

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ClinicalTrials.gov Identifier: NCT02398357
Recruitment Status : Unknown
Verified December 2015 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : March 25, 2015
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

Brief Summary:
To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Liver Cirrhosis Drug: Nadroparin Calcium and Warfarin Phase 4

Detailed Description:
The treatment of cirrhotic patients with PVT (portal vein thrombosis) is clearly recommended in guideline now. Several published studies has confirm the effect and safety of anticoagulation therapy in cirrhotic patients with PVT.The present studies are most observation studies with small sample size and low quality.We need more high-quality research such as randomized controlled trials. This is a Zelen-designed randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then we will make sure wether their are fond of the group and make decision by themselves. The recanalization rate and complications will be analyzed

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Zelen-design Randomized Controlled Trial of the Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis
Study Start Date : March 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
No Intervention: Control
No anticoagulation,just routine follow-up
Experimental: Anticoagulation
Nadroparin Calcium and Warfarin
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,alone with Nadroparin Calcium 4100IU/d,subcutaneous, when taking endoscopy therapy .




Primary Outcome Measures :
  1. Recanalization rate of PVT [ Time Frame: 8 weeks ]
    Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks


Secondary Outcome Measures :
  1. Rebleeding rate [ Time Frame: 8 weeks ]
    The investigators observe the variceal rebleeding events during 8 weeks.

  2. Incidence rate of complications [ Time Frame: 8 weeks ]
    The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.



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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
Criteria

Inclusion Criteria:

  • Age between 18-70 years old;
  • A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
  • Diagnosed of Portal vein thrombosis;
  • Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
  • Have undergone endoscopy to prevent variceal rebleeding.

Exclusion Criteria:

  • Age <18 or >70 years;
  • Portal vein thrombosis diagnosed before 6 months;
  • Patients with signs of acute PVT such as fever,abdominal pain or intestinal obstruction,who should be treated immediately;
  • Pregnant or nursing;
  • Hepatocellular carcinoma;
  • Severe cardiopulmonary diseases or concomitant renal insufficiency;
  • cavernous transformation of the portal vein;
  • Contradictions to endoscopy;
  • Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis,sustained platelet count < 50 x103/uL);
  • Taking immunosuppressive agent;
  • Coagulation disorders other than the liver disease related;
  • Variceal bleeding failed to control.

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 ClinicalTrials.gov identifier (NCT number): NCT02398357


Contacts
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Contact: Shiyao Chen, Professor 86-13601767310 chen.shiyao@zs-hospital.sh.cn

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Shenxin Lu, Doctor    86-13611843734    08301010239@fudan.edu.cn   
Principal Investigator: Shiyao Chen, MD         
Sub-Investigator: Shenxin Lu         
Sub-Investigator: Jian Wang, MD         
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital

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Responsible Party: Shiyao Chen, department of Gastroenterology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02398357     History of Changes
Other Study ID Numbers: CSY-LSX-2015
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
anticoagulation
Zelen-designed randomized controlled trial
Additional relevant MeSH terms:
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Liver Cirrhosis
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Calcium, Dietary
Nadroparin
Warfarin
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action