Efficacy and Safety of Dabigatran in Patients With Cirrhosis and Portal Vein Thrombosis

NCT ID: NCT04433481

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-20
• Study Completion Date: 2022-05-31

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 -

1. Etiology of cirrhosis

2. Upper GI endoscopy

3. Haemogram (including reticulocyte count)

4. Coagulogram- PT/INR,APTT,TEG

5. Prothrombotic profile- protein c/protein-s/AT-III/Factor V Leiden mutation/ MTHFR C677T/PROTHROMBIN G20210A/ JAK2 V617F MUTATION / Anticardiolipin Ab.

6. Liver function tests, Renal function tests

7. Alpha fetoprotein/PIVKA II

8. USG abdomen with Doppler study

9. CECT-TP or CEMRI-TP to R/O HCC or angiography when PVT diagnosis doubtful.

10. HVPG+LIVER BIOPSY[optional]

11. Fibro scan

12. Child-Pugh score, MELD Subsequently, patients will be assessed clinically at the baseline and post-treatment every2 months till 18 months

Statistical Analysis:

The data collected will be analyzed using SPSS ver 22 by standard statistical analysis, were numerical data will be analyzed to find mean, median scores and categorical data will be analyzed using Chi square test and continuous data will be analyzed by student T test and any association will be analyzed by the univariate and multivariate analysis, log regression analysis along with ROC curve will be used and p<0.05 will be considered significant and results will be appropriately tabulated

Adverse Effects Hemorrhage - Fatal Major - intracranial, retroperitoneal, intraocular, muscle hematoma Minor TREATMENT IN CASE OF ADVERSE EFFECTS - Withdrawal of drug

Stopping rule of study Allergic reactions to drug Severe hemorrhage DIC Progression of PVT after 6 months viral reactivation leading to ACLF, acute hepatitis (viral, drug related, autoimmune flare), sepsis with severe coagulopathy

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DABIGATRAN

150mg BD for 12 months

Group Type: EXPERIMENTAL

Dabigatran

Intervention Type: DRUG

T. Dabigatran 150 mg twice a day

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo

Interventions

Dabigatran

T. Dabigatran 150 mg twice a day

Intervention Type: DRUG

Placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Clinical / radiological /histologic diagnosis of cirrhosis [Childs A&B - CTP<9]

2. Partial / total portal vein thrombosis (chronic)

3. Age- 18-70 years

4. Valid consent

Exclusion Criteria

1. Age > 70 years

2. Presence of active infection (<2 weeks)

3. Use of anticoagulant drugs in the past 10 days

4. Pregnancy

5. HIV positivity

6. Recent (<7 days) transfusion with blood products.

7. History of bleeding in last 42 days

8. HCC / Other malignancy

9. Chronic kidney disease [ CrCl< 30]

10. Drug allergies

11. PVT with cavernoma formation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr G. Srinivasa Reddy, MD

Role: CONTACT

srinivasareddygolamari@gmail.com

01146300000

Facility Contacts

Dr G Srinivasa Reddy, MD

Role: primary

srinivasareddygolamari@gmail.com

01146300000

Other Identifiers

ILBS-Cirrhosis-30

Identifier Type: -

Identifier Source: org_study_id