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Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection (ESAPT)

Primary Purpose

Cirrhosis, Splenectomy, Venous Thrombosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Apixaban 2.5 MG
Dipyridamole 25Mg Tab
subcutaneous Low Molecular Weight Heparin
Sponsored by
Guo-Qing Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cirrhosis focused on measuring Cirrhosis, Venous thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
  2. Splenomegaly with secondary hypersplenism
  3. Bleeding portal hypertension
  4. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
  5. Informed consent to participate in the study

Exclusion Criteria:

  1. Hepatocellular carcinoma or any other malignancy,
  2. Hypercoagulable state other than the liver disease related
  3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
  4. Child - Pugh C
  5. Recent peptic ulcer disease
  6. History of Hemorrhagic stroke
  7. Pregnancy.
  8. Uncontrolled Hypertension
  9. Human immunodeficiency virus (HIV) infection

Sites / Locations

  • Clinical Medical College, Yangzhou University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apixaban group

Arm Description

From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.

Outcomes

Primary Outcome Measures

Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
Proportion of participants with Main and intrahepatic branches of portal vein thrombosis by ultrasound evaluation

Secondary Outcome Measures

Proportion of participants with Splenic vein thrombosis
Proportion of participants withSplenic vein thrombosis by ultrasound evaluation
Proportion of participants with Mesenteric vein thrombosis
Proportion of participants with Mesenteric vein thrombosis by ultrasound evaluation

Full Information

First Posted
March 19, 2022
Last Updated
July 23, 2023
Sponsor
Guo-Qing Jiang
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1. Study Identification

Unique Protocol Identification Number
NCT05304455
Brief Title
Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection
Acronym
ESAPT
Official Title
Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guo-Qing Jiang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Apixaban is effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy and Azygoportal Disconnection
Detailed Description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. The Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (POD) 7, at postoperative months (POM) 1, 3, and 6. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done as per the primary outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Splenectomy, Venous Thrombosis, Hypertension, Portal
Keywords
Cirrhosis, Venous thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban group
Arm Type
Experimental
Arm Description
From postoperative day 3, Patients will receive oral Dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Apixaban 2.5 MG
Other Intervention Name(s)
ELIQUIS
Intervention Description
From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.
Intervention Type
Drug
Intervention Name(s)
Dipyridamole 25Mg Tab
Other Intervention Name(s)
Persantine
Intervention Description
From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.
Intervention Type
Drug
Intervention Name(s)
subcutaneous Low Molecular Weight Heparin
Other Intervention Name(s)
LMWHs
Intervention Description
From postoperative day 3, Patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin injection for first five days and 2.5 mg oral Apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) twice daily for 6 months.The Doppler Ultra Sonography screening will be done to assess the occurrence of portal vein thrombus.
Primary Outcome Measure Information:
Title
Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis
Description
Proportion of participants with Main and intrahepatic branches of portal vein thrombosis by ultrasound evaluation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of participants with Splenic vein thrombosis
Description
Proportion of participants withSplenic vein thrombosis by ultrasound evaluation
Time Frame
6 months
Title
Proportion of participants with Mesenteric vein thrombosis
Description
Proportion of participants with Mesenteric vein thrombosis by ultrasound evaluation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical, radiological or histologic diagnosis of cirrhosis of any etiology Splenomegaly with secondary hypersplenism Bleeding portal hypertension 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. Child - Pugh C Recent peptic ulcer disease History of Hemorrhagic stroke Pregnancy. Uncontrolled Hypertension Human immunodeficiency virus (HIV) infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Chen, MD
Organizational Affiliation
Clinical Medical College, Yangzhou University
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Medical College, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Apixaban Prevents Portal Vein Thrombosis After Laparoscopic Splenectomy and Azygoportal Disconnection

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