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Safety of Anticoagulant Therapy After Endoscopic Treatment

Primary Purpose

Cirrhosis, Portal Vein Thrombosis, Esophageal and Gastric Varices

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
nadroparin calcium-warfarin sequential anticoagulation
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of cirrhosis
  • Portal hypertension with esophageal and gastric varices
  • diagnosis of PVT by imaging examination
  • undergo endoscopic therapy

Exclusion Criteria:

  • older than 75 years
  • uncontrolled active bleeding
  • hepatocellular carcinoma or other extrahepatic malignancy
  • on-going or received antithrombotic/thrombolytic treatment
  • previous treatment with TIPSS
  • cavernous transformation of the portal vein
  • platelet count lower than 10*10 ^ 9/L, creatinine more than 170 μmol/L
  • Budd-Chiari syndrome
  • pregnancy or breast-feeding period
  • severe cardiopulmonary diseases, severe systemic infection or sepsis
  • inability to sign informed consent

Sites / Locations

  • Department of Gastroenterology,Qilu Hospital,Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NWS group

control group

Arm Description

nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months

no anticoagulation therapy

Outcomes

Primary Outcome Measures

rate of overall recanalization
the sum of the fraction of patients who had complete or partial recanalization
rate of bleeding
rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events

Secondary Outcome Measures

Full Information

First Posted
July 15, 2021
Last Updated
October 8, 2022
Sponsor
Qilu Hospital of Shandong University
Collaborators
Liaocheng People's Hospital, Taian City Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04976543
Brief Title
Safety of Anticoagulant Therapy After Endoscopic Treatment
Official Title
Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University
Collaborators
Liaocheng People's Hospital, Taian City Central Hospital

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 investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.
Detailed Description
Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Vein Thrombosis, Esophageal and Gastric Varices, Anticoagulant-induced Bleeding
Keywords
endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NWS group
Arm Type
Experimental
Arm Description
nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months
Arm Title
control group
Arm Type
No Intervention
Arm Description
no anticoagulation therapy
Intervention Type
Drug
Intervention Name(s)
nadroparin calcium-warfarin sequential anticoagulation
Other Intervention Name(s)
anticoagulation
Intervention Description
The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
Primary Outcome Measure Information:
Title
rate of overall recanalization
Description
the sum of the fraction of patients who had complete or partial recanalization
Time Frame
6-month
Title
rate of bleeding
Description
rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of cirrhosis Portal hypertension with esophageal and gastric varices diagnosis of PVT by imaging examination undergo endoscopic therapy Exclusion Criteria: older than 75 years uncontrolled active bleeding hepatocellular carcinoma or other extrahepatic malignancy on-going or received antithrombotic/thrombolytic treatment previous treatment with TIPSS cavernous transformation of the portal vein platelet count lower than 10*10 ^ 9/L, creatinine more than 170 μmol/L Budd-Chiari syndrome pregnancy or breast-feeding period severe cardiopulmonary diseases, severe systemic infection or sepsis inability to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanjing Gao, PhD.MD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology,Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety of Anticoagulant Therapy After Endoscopic Treatment

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