Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 293 for:    warfarin AND anticoagulation

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

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: 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

Tracking Information
First Submitted Date  ICMJE December 8, 2015
First Posted Date  ICMJE December 15, 2015
Last Update Posted Date December 15, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  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 The Effect of Anticoagulation in Cirrhotic Patients With Portal Vein Thrombosis:A Multicenter RCT
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Portal Vein Thrombosis
  • Liver Cirrhosis
Intervention  ICMJE
  • 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  ICMJE
  • 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

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

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  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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02630095
Other Study ID Numbers  ICMJE CSY-LSX02-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shiyao Chen, Shanghai Zhongshan Hospital
Study Sponsor  ICMJE Shanghai Zhongshan Hospital
Collaborators  ICMJE
  • 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  ICMJE
Study Director: Shiyao Chen, Professor Shanghai Zhongshan Hospital
PRS Account Shanghai Zhongshan Hospital
Verification Date December 2015

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