Clinical trial NCT06818279: Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis
Official title: Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Portal Vein Thrombosis
Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.

Detailed description: Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size - 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis.

Study period -1 year Monitoring and assessment

* At enrollment:

  1. Complete history and physical examination
  2. Etiology of cirrhosis
  3. Presenting symptoms
  4. Severity of ascites, Jaundice
  5. Pattern and number of prior decompensation
  6. UGIE and variceal status
  7. Complete physical evaluation
  8. Hemogram, Kidney function test, Liver function test, INR
  9. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
  10. Fibroscan-liver and spleen
  11. 2D-ECHO, ECG
  12. AFP At follow-up (1month, 3 month, 6 month, 9 month 12month)

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  1. Complete history and physical examination
  2. Pattern and number of decompensation
  3. MELD, CTP, APRI, ALBI Score
  4. Hemogram, Kidney function test, Liver function test, INR
  5. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.

Exclusion Criteria:

1. Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
2. CTP \>10
3. Hepatocellular carcinoma
4. Tumoral PVT
5. Isolated gastric varices with red colour signs
6. Peptic ulcer disease with large ulcers
7. Pregnant or breastfeeding women
8. Thrombocytopenia (platelet count \<50,000/μL)
9. Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
10. Those not giving consent for therapy

Primary outcomes:
measure: Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.
timeFrame: 6 months
Secondary outcomes:
measure: Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.
timeFrame: 6 months
measure: Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.
timeFrame: 6 months
measure: Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.
timeFrame: 3 months
measure: Rate of recurrence of Portal Vein Thrombosis at 12 months.
timeFrame: 12 months
measure: Adverse events in both the groups till 6-months
timeFrame: 6 months
measure: Change in CTP scores in both the groups over 12-months
timeFrame: 12-months
measure: Change in MELD scores in both the groups over 12-months
timeFrame: 12-months
measure: Variceal and non-variceal bleeding rates at 6-months and 12-months
timeFrame: 6-months and 12-months
measure: Number of patients with worsening of decompensation events and new onset decompensation events in the two study groups till 12-months
timeFrame: 12-months
measure: Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups.
timeFrame: 12 months
measure: Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
References: