NCT04527666

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

August 23, 2020

Last Update Submit

August 25, 2020

Conditions

Gastroesophageal VaricesJAK2 MutationMyeloproliferative Neoplasm

Keywords

portal hypertensiongastroesophageal varicesjak2 mutationmyeloproliferative neoplasm

Outcome Measures

Primary Outcomes (1)

  • Changes of portal vein thrombosis

    The changes of portal vein thrombosis including progression, disappear or unchanged.

    1 year

Secondary Outcomes (2)

  • The occurrence of variceal bleeding

    1 year

  • Overall survival

    1 year

Study Arms (2)

Anticoagulation group

Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents.

Drug: Anticoagulation Agents

Control group

Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents.

Interventions

Anticoagulation AgentsDRUG

Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.

Anticoagulation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Greenfield G, McMullin MF. Splanchnic venous thrombosis in JAK2 V617F mutation positive myeloproliferative neoplasms - long term follow-up of a regional case series. Thromb J. 2018 Dec 19;16:33. doi: 10.1186/s12959-018-0187-z. eCollection 2018.

    PMID: 30574023BACKGROUND

  • Yan M, Geyer H, Mesa R, Atallah E, Callum J, Bartoszko J, Yee K, Maganti M, Wong F, Gupta V. Clinical features of patients with Philadelphia-negative myeloproliferative neoplasms complicated by portal hypertension. Clin Lymphoma Myeloma Leuk. 2015 Jan;15(1):e1-5. doi: 10.1016/j.clml.2014.04.004. Epub 2014 Jun 11.

    PMID: 25027569BACKGROUND

  • Magaz M, Alvarez-Larran A, Colomer D, Lopez-Guerra M, Garcia-Criado MA, Mezzano G, Belmonte E, Olivas P, Soy G, Cervantes F, Darnell A, Ferrusquia-Acosta J, Baiges A, Turon F, Hernandez-Gea V, Garcia-Pagan JC. Next-generation sequencing in the diagnosis of non-cirrhotic splanchnic vein thrombosis. J Hepatol. 2021 Jan;74(1):89-95. doi: 10.1016/j.jhep.2020.06.045. Epub 2020 Jul 15.

    PMID: 32679300BACKGROUND

  • Reilly CR, Babushok DV, Martin K, Spivak JL, Streiff M, Bahirwani R, Mondschein J, Stein B, Moliterno A, Hexner EO. Multicenter analysis of the use of transjugular intrahepatic portosystemic shunt for management of MPN-associated portal hypertension. Am J Hematol. 2017 Sep;92(9):909-914. doi: 10.1002/ajh.24798. Epub 2017 Jul 26.

    PMID: 28543980RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersHypertension, Portal

Interventions

Anticoagulants

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Hematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Xiaoquan HUANG, Ph.D

CONTACT

18801733835huang.xiaoquan@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 26, 2020

Study Start

October 1, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2022

Last Updated

August 27, 2020

Record last verified: 2020-08