Clinical TrialID 5542
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
NCT04173429
Liver Cirrhosis|Portal Vein Thrombosis
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5542
- Evidence Id
- 5542
- Core Evidence Id
- 5542
- Source Clinical Trial Id
- 5524
- Herb2 Clinical Trial Id
- HBCT005524
- Nct Id
- NCT04173429
- Title
- Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
- Status
- Completed
- Phase
- Phase 4
- Study Result
- Yes
- Study Condition
- Liver Cirrhosis|Portal Vein Thrombosis
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Nadroparin calcium, warfarin
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Single
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 64
- Outcome Measure
- Recanalization Rate, For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins., 6 months
- Sponsor Collaborator
- Qilu Hospital of Shandong University
- Funded By
- OTHER
- Location
- Department of Gastroenterology,Qilu Hospital,Shandong University, Jinan, Shandong, 250012, China
- Other Id
- 2019126-QILU
- Start Date
- 2017-01-01
- Primary Completion Date
- 2020-01-31
- Completion Date
- 2020-01-31
- First Posted
- 2019-11-22
- Results First Posted
- 2021-03-02
- Last Update Posted
- 2021-03-02
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/29/NCT04173429/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/29/NCT04173429/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT04173429
- Title Cn
- Title En
- Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
- Bilingual Status
- semi_complete