Anticoagulation in Gastroesophageal Varices and JAK2 Mutation

August 25, 2020 updated by: XiaoquanHUANG, Shanghai Zhongshan Hospital

Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with gastric and/or esophageal varices and JAK2 mutation.

Description

Inclusion Criteria:

  • Male or female patients aged 18-75
  • diagnosed as portal hypertension by contrast-enhanced computed tomography
  • diagnosed as JAK2 positive

Exclusion Criteria:

  • not had portal contrast-enhanced computed tomography
  • not had JAK2 mutation test
  • other factors judged by the investigator that may affect the safety of the subject or the compliance of the trial. Such as serious illnesses (including mental illness) that require combined treatment, serious laboratory abnormalities, or other family or social factors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anticoagulation group
Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents.
Drug: Anticoagulation Agents
Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.
Control group
Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of portal vein thrombosis
Time Frame: 1 year
The changes of portal vein thrombosis including progression, disappear or unchanged.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of variceal bleeding
Time Frame: 1 year
The occurrence of variceal bleeding including haematemesis and melena
1 year
Overall survival
Time Frame: 1 year
Overall survival rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

August 23, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-ANTICO-JAK2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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