Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Myeloproliferative Disorders
  • Myeloproliferative Neoplasm
  • Splanchnic Vein Thrombosis
  • Splanchnic Venous Thrombosis
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Study Title Morbidity and portal circulation in patients with Myeloproliferative neoplasms and splanchnic vein thrombosis: Mascot Protocol No. MPN-SVT v11; 02/Dec/2013 Study Design Prospective observational longitudinal study of patients with MPN related splanchnic vein thrombosis(study group) and p...

Study Title Morbidity and portal circulation in patients with Myeloproliferative neoplasms and splanchnic vein thrombosis: Mascot Protocol No. MPN-SVT v11; 02/Dec/2013 Study Design Prospective observational longitudinal study of patients with MPN related splanchnic vein thrombosis(study group) and patients with MPN without SVT (control group) Study Participants Patients with myeloproliferative neoplasms (MPN) and splanchnic vein thrombosis (SVT), patients with MPN and splenomegaly. Number of subjects 40 patients Follow-up duration 5 years Study duration January 2014- January 2019. Primary Objectives 1. To describe morbidity/portal circulation in the patient group over the 18m from baseline 2. To examine if there are changes in endpoints from baseline to 18m 3. To compare patients with MPN related SVT and MPN without SVT Secondary Objectives 1. To describe morbidity/portal circulation in the patient group over 5 years from baseline 2. To examine if there are changes in endpoints from baseline to 5 years 3. To assess the impact of treatment including cytoreductive therapy, Janus kinase (JAK) inhibition and antithrombotic treatment on end points. 4. To assess adequacy of anti-thrombotic agents with reference to recurrence, recanalisation and extension of splanchnic thrombosis, non-splanchnic thrombotic events and bleeding frequency. Exploratory objectives 1. Assess the utility of endothelial colony assay as marker of disease 2. Assess the utility of adhesion molecules as markers of disease Primary Endpoint Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months Secondary Endpoint Occurence or change in morbidity or portal circulation over 3-5 years

Tracking Information

NCT #
NCT04631458
Collaborators
University Hospital Birmingham
Investigators
Not Provided