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The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis:A Multicenter RCT

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ClinicalTrials.gov Identifier: NCT02630095
Recruitment Status : Unknown
Verified December 2015 by Shiyao Chen, Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Collaborators:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
ShuGuang Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Pudong New Area Gongli Hospital
Eastern Hepatobiliary Surgery Hospital
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

Brief Summary:
The purpose of this study is to determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore its effect on long-term rebleeding rate and mortality.

Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Liver Cirrhosis Drug: Nadroparin Calcium and Warfarin Device: Doppler ultrasound and CT 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. The investigators need more high-quality research such as randomized controlled trials. This is a Zelen-designed multicenter randomized controlled trial. Patients will randomly enter into two groups:the anticoagulation group or the control group and then the investigator 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: Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis:A Zelen-design Multicenter Randomized Controlled Trial
Study Start Date : December 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Warfarin

Arm Intervention/treatment
Control.
No anticoagulation,just routine follow up.
Device: Doppler ultrasound and CT
all patient will take Doppler ultrasound examination every 3 months ;Abdominal CT will be done every 6 months。

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, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU/d,subcutaneous.

Device: Doppler ultrasound and CT
all patient will take Doppler ultrasound examination every 3 months ;Abdominal CT will be done every 6 months。




Primary Outcome Measures :
  1. Recanalization rate of PVT [ Time Frame: through study completion,an average of 18 months ]
    Patients will receive Doppler ultrasound and CT before enrolled and followed up by Doppler ultrasound every 3 months ,by CT every 6 months after enrolled,untill the end of the study.


Secondary Outcome Measures :
  1. Rebleeding rate [ Time Frame: through study completion,an average of 18 months ]
    The investigators observe the variceal rebleeding events during the study

  2. Incidence rate of complications [ Time Frame: through study completion,an average of 18 months ]
    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 or other cancer;
  • 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 x10^9/L);
  • 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): NCT02630095


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
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Public Health Clinical Center
ShuGuang Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Pudong New Area Gongli Hospital
Eastern Hepatobiliary Surgery Hospital
Investigators
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Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital

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Responsible Party: Shiyao Chen, Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02630095     History of Changes
Other Study ID Numbers: CSY-LSX02-2015
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Shiyao Chen, Shanghai Zhongshan Hospital:
anticoagulation

Additional relevant MeSH terms:
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Thrombosis
Liver Cirrhosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Calcium
Calcium, Dietary
Warfarin
Nadroparin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action