Warfarin Prevents Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy

Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy

Sponsors

Lead Sponsor: Yangzhou University

Source Yangzhou University
Brief Summary

The purpose of this study is to determine whether Warfarin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients with Hypersplenism after Laparoscopic Splenectomy.

Detailed Description

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (warfarin) or control (aspirin) group. From postoperative day 3, patients in interventional (warfarin) group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year, patients in control (aspirin) group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year, and both groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every 3 months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. Both groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then one year monitoring will be done in the both groups as per the primary or secondary outcome.

Overall Status Recruiting
Start Date September 1, 2014
Completion Date September 30, 2019
Primary Completion Date September 30, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportions of patients who will suffer from PVT or spleno-mesenteric thrombosis between oral anticoagulant Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period of 3 year from randomization 3 years
Secondary Outcome
Measure Time Frame
Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups 3 years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups 3 years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection 3 years
Proportions of patients who will suffer from hepatocellular carcinoma 3 years
Overall survival in both groups 3 years
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Warfarin

Description: From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.

Arm Group Label: Warfarin with dipyridamole

Intervention Type: Drug

Intervention Name: Dipyridamole

Description: From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.

Intervention Type: Drug

Intervention Name: Aspirin

Description: From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.

Arm Group Label: Aspirin with dipyridamole

Intervention Type: Drug

Intervention Name: Low Molecular Weight Heparin

Description: From postoperative day 3, Patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.

Other Name: Fraxiparine

Eligibility

Criteria:

Inclusion Criteria:

- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology

- Splenomegaly with secondary hypersplenism, Platelet count < 50*10^9/L

- No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT

- Informed consent to participate in the study

Exclusion Criteria:

- Hepatocellular carcinoma or any other malignancy

- Hypercoagulable state other than the liver disease related

- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs

- Base line INR >2

- Child-Pugh grade C

- Recent peptic ulcer disease

- History of Hemorrhagic stroke

- Pregnancy

- Uncontrolled Hypertension

- Age>75 yrs

- F2 varices with red whale marks or F3 varices

- Bleeding portal hypertension

- Human immunodeficiency virus (HIV) infection

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Guo-Qing Jiang, MS

Phone: 86-514-87373272

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Clinical Medical College of Yangzhou University Luo-Jing Zhou, MD 86-514-87373037 [email protected] Dou-Sheng Bai, MD Principal Investigator
Location Countries

China

Verification Date

December 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Yangzhou University

Investigator Full Name: Guo-Qing Jiang

Investigator Title: Master

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Warfarin with dipyridamole

Type: Experimental

Description: From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for one year irrespective of the occurrence of portal vein thrombus.

Label: Aspirin with dipyridamole

Type: Active Comparator

Description: From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for one year.

Acronym ESWA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov