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

• ClinicalTrials.gov Identifier: NCT02630095
• Recruitment Status: Unknown
• First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Sponsor: Shanghai Zhongshan Hospital
• 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

Tracking Information

• First Submitted Date: December 8, 2015
• First Posted Date: December 15, 2015
• Last Update Posted Date: December 15, 2015
• Study Start Date: December 2015
• Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 14, 2015)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 14, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis：A Multicenter RCT
• Official Title: Effect of Anticoagulation After Endoscopic Therapy in Cirrhotic Patients With Portal Vein Thrombosis：A Zelen-design Multicenter Randomized Controlled Trial
• 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.
• 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
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Portal Vein Thrombosis
• Liver Cirrhosis

Intervention

• 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。

Study Arms

• Control.
  No anticoagulation，just routine follow up.
  Intervention: Device: Doppler ultrasound and CT
• Experimental: Anticoagulation
  Nadroparin Calcium and Warfarin
  Interventions:

  • Drug: Nadroparin Calcium and Warfarin
  • Device: Doppler ultrasound and CT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 14, 2015): 96
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2018
• Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02630095
• Other Study ID Numbers: CSY-LSX02-2015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Shiyao Chen, Shanghai Zhongshan Hospital
• Study Sponsor: Shanghai Zhongshan Hospital

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

Investigators

• Study Director: Shiyao Chen, Professor; Shanghai Zhongshan Hospital

• PRS Account: Shanghai Zhongshan Hospital
• Verification Date: December 2015