Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis-A Randomized Placebo Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Number of participants with complete recanalization of thrombus in both groups.
Study Overview
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.
Detailed Description
Study population -All the patients of cirrhosis of liver patients visiting to ILBS and diagnosed to have non tumor portal vein thrombosis will be enrolled in the study.
Study Design - A Placebo Controlled Double Blinded RCT In this randomized controlled trial, the patients who satisfy the below inclusion and exclusion criteria will be included and they will be randomized, according to 2 groups (in total 84patients) to receive either Placebo or dabigatran 150 mg BD for 12months. These patients will be admitted to the hospital from OPD or emergency.
Study period - 1.5 years from ethics approval Intervention The patients in Group A will receive T. Dabigatran 150 mg twice a day .The patients in Group B will receive placebo [multivitamins] Monitoring and assessment At baseline, a complete history with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done. All included patients will be evaluated with -
- Etiology of cirrhosis
- Upper GI endoscopy
- Haemogram (including reticulocyte count)
- Coagulogram- PT/INR,APTT,TEG
- Prothrombotic profile- protein c/protein-s/AT-III/Factor V Leiden mutation/ MTHFR C677T/PROTHROMBIN G20210A/ JAK2 V617F MUTATION / Anticardiolipin Ab.
- Liver function tests, Renal function tests
- Alpha fetoprotein/PIVKA II
- USG abdomen with Doppler study
- CECT-TP or CEMRI-TP to R/O HCC or angiography when PVT diagnosis doubtful.
- HVPG+LIVER BIOPSY[optional]
- Fibro scan
- Child-Pugh score, MELD Subsequently, patients will be assessed clinically at the baseline and post-treatment every2 months till 18 months
Statistical Analysis:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical / radiological /histologic diagnosis of cirrhosis [Childs A&B - CTP<9]
- •Partial / total portal vein thrombosis (chronic)
- •Age- 18-70 years
- •Valid consent
Exclusion Criteria
- •Age > 70 years
- •Presence of active infection (<2 weeks)
- •Use of anticoagulant drugs in the past 10 days
- •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
Arms & Interventions
DABIGATRAN
150mg BD for 12 months
Intervention: Dabigatran (Drug)
Placebo
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Number of participants with complete recanalization of thrombus in both groups.
Time Frame: 1 year
Secondary Outcomes
- Number of participants with partial recanalization of thrombus in both groups.(1 Year)
- Number of participants with prevention of secondary decompensation in both groups(1 Year)
- To determine predictors for recurrence of PVT in patients with cirrhosis.(1 year)
- To study the predictors of development of PVT in the population of cirrhosis patients screened who did not have PVT at the initiation of the study, for the development of new PVT over the period of the study(1 year)
- Adverse Events in both groups(1 year)
- To study the number of participants developing reoccurrence of PVT after treatment with Dabigatran for 12 months by Ultrasound Doppler of splenoportal venous system.(12 months)
- Improvements in Model for End Stage Liver Disease (MELD) Score in both groups(1 Year)
- Number of participants with improvements in Child-Turcotte-Pugh (CTP) in both groups.(1 year)
- To study the changes in coagulation parameters by ROTEM(Rotational Thrombo Elastometry) analysis which includes CFT(clot formation time).(12 Months)
- Number of participants with reduction in clinical complications in patients with PVT in both groups(12 Months)