Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02238444
Other study ID # YZUC-001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2014
Est. completion date September 30, 2019

Study information

Verified date December 2018
Source Yangzhou University
Contact Guo-Qing Jiang, MS
Phone 86-514-87373272
Email jgqing2003@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

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.
Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Aspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
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.

Locations

Country Name City State
China Clinical Medical College of Yangzhou University Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Proportions of patients who will show improvement in Child Pugh (>2 points)in both groups 3 years
Secondary Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points)in both groups 3 years
Secondary 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
Secondary Proportions of patients who will suffer from hepatocellular carcinoma 3 years
Secondary Overall survival in both groups 3 years
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A