NCT02238444

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Yangzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Hypertension
• Venous Thrombosis
• Status; Splenectomy

Interventions

Type	Name	Description
DRUG	Warfarin	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.
DRUG	Dipyridamole	From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
DRUG	Aspirin	From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
DRUG	Low Molecular Weight Heparin	From postoperative day 3, Patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2014-09-12
• Last updated: 2019-01-02

Locations

1 site across 1 country: China