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

NCT02630095 | Unknown Phase 4

• 1 other identifier: CSY-LSX02-2015
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Vein Thrombosis; Liver Cirrhosis

Keywords

anticoagulation

Outcome Measures

Primary Outcomes (1)

• Recanalization rate of PVT

  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.

  through study completion，an average of 18 months

Secondary Outcomes (2)

• Rebleeding rate

  through study completion，an average of 18 months

• Incidence rate of complications

  through study completion，an average of 18 months

Study Arms (2)

Control.

OTHER

No anticoagulation，just routine follow up.

Device: Doppler ultrasound and CT

Anticoagulation

EXPERIMENTAL

Nadroparin Calcium and Warfarin

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

Interventions

Nadroparin Calcium and Warfarin DRUG

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.

Anticoagulation

Doppler ultrasound and CT DEVICE

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

Anticoagulation; Control.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Public Health Clinical Center: collaborator
• ShuGuang Hospital: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Nadroparin; Warfarin; Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Shiyao Chen, Professor

  Shanghai Zhongshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310; chen.shiyao@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of Gastroenterology, Zhongshan Hospital

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 15, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

CN (1)