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Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

Primary Purpose

Liver Cirrhosis, Portal Vein Thrombosis

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

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Portal vein thrombosis, Nadroparin calcium, Warfarin, Anticoagulation

Eligibility Criteria

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

Inclusion Criteria:

  • Age between 18 and 75 years
  • Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography

Exclusion Criteria:

  • Cavernous transformation of the portal vein
  • Uncontrolled active bleeding
  • Platelet count lower than 10*10^9/L
  • Creatinine more than 170 mmol/L
  • Ongoing or received antithrombotic/thrombolytic treatment
  • Primary thrombophilia
  • 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

nadroparin calcium-warfarin sequential therapy group

Control group

Arm Description

nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months

No anticoagulation therapy.

Outcomes

Primary Outcome Measures

Recanalization Rate
For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins.

Secondary Outcome Measures

Rate of Bleeding
Risk of bleeding episodes

Full Information

First Posted
November 20, 2019
Last Updated
March 1, 2021
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04173429
Brief Title
Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Official Title
Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients：A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

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 study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
Detailed Description
Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Vein Thrombosis
Keywords
Portal vein thrombosis, Nadroparin calcium, Warfarin, Anticoagulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
nadroparin calcium-warfarin sequential therapy group
Arm Type
Experimental
Arm Description
nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin 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
Other Intervention Name(s)
Experimental group
Intervention Description
Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) 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
Recanalization Rate
Description
For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of Bleeding
Description
Risk of bleeding episodes
Time Frame
6 months

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: Age between 18 and 75 years Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography Exclusion Criteria: Cavernous transformation of the portal vein Uncontrolled active bleeding Platelet count lower than 10*10^9/L Creatinine more than 170 mmol/L Ongoing or received antithrombotic/thrombolytic treatment Primary thrombophilia 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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Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

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