Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis
1 other identifier
interventional
84
1 country
1
Brief Summary
A randomized controlled trial to study the efficacy and safety of Dabigatran in Cirrhotic patients who develop PVT.In this study the patients who meet the inclusion criteria will be randomized to either receive Dabigatran or placebo \[multivitamin tablet\]. Blood samples will be taken \&Imaging will be done accordingly to notice progression or recanalization of PVT.The patients are followed up every 2 months up to 18 month .Then statistical analysis will be done to find whether the Dabigatran is efficacious in cirrhotic patients for recanalization of PVT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
June 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedAugust 25, 2021
August 1, 2021
1.9 years
May 29, 2020
August 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with complete recanalization of thrombus in both groups.
1 year
Secondary Outcomes (15)
Number of participants with partial recanalization of thrombus in both groups.
1 Year
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
6 months
Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.
1 year
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
6 months
Improvements in Model for End Stage Liver Disease (MELD) Score in both groups
1 Year
- +10 more secondary outcomes
Study Arms (2)
DABIGATRAN
EXPERIMENTAL150mg BD for 12 months
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Clinical / radiological /histologic diagnosis of cirrhosis \[Childs A\&B - CTP\<9\]
- Partial / total portal vein thrombosis (chronic)
- Age- 18-70 years
- Valid consent
You may not qualify if:
- Age \> 70 years
- Presence of active infection (\<2 weeks)
- Use of anticoagulant drugs in the past 10 days
- Pregnancy
- HIV positivity
- Recent (\<7 days) transfusion with blood products.
- History of bleeding in last 42 days
- HCC / Other malignancy
- Chronic kidney disease \[ CrCl\< 30\]
- Drug allergies
- PVT with cavernoma formation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 16, 2020
Study Start
June 20, 2020
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
August 25, 2021
Record last verified: 2021-08