Phase 4
N=64
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Liver Cirrhosis · Portal Vein Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT04173429 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Recanalization Rate — 20; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nadroparin calcium, warfarin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Qilu Hospital of Shandong University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recanalization Rate |
20; 11 | — |
| SECONDARY Rate of Bleeding |
1; 0 | — |
Summary
The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 75 years
- Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography
Exclusion Criteria
- Cavernous transformation of the portal vein
- Uncontrolled active bleeding
- Platelet count lower than 10*10^9/L
- Creatinine more than 170 mmol/L
- Ongoing or received antithrombotic/thrombolytic treatment
- Primary thrombophilia
- Budd-Chiari syndrome
- Pregnancy or breast-feeding period
- Severe cardiopulmonary diseases
- Severe systemic infection or sepsis
- Inability to sign informed consent
Data sourced from ClinicalTrials.gov (NCT04173429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.