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
|Condition or disease||Intervention/treatment||Phase|
|Portal Vein Thrombosis Liver Cirrhosis||Drug: Nadroparin Calcium and Warfarin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
No anticoagulation，just routine follow-up
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 .
- Recanalization rate of PVT [ Time Frame: 8 weeks ]Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks
- Rebleeding rate [ Time Frame: 8 weeks ]The investigators observe the variceal rebleeding events during 8 weeks.
- Incidence rate of complications [ Time Frame: 8 weeks ]The investigators observe any severe adverse events caused by anticoagulation therapy or the progress of thrombosis.
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
|Contact: Shiyao Chen, Professorfirstname.lastname@example.org|
|Shanghai Zhongshan Hospital||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: Shenxin Lu, Doctor 86-13611843734 email@example.com|
|Principal Investigator: Shiyao Chen, MD|
|Sub-Investigator: Shenxin Lu|
|Sub-Investigator: Jian Wang, MD|
|Study Director:||Shiyao Chen, Professor||Shanghai Zhongshan Hospital|