Outcomes in Patients With Myeloproliferative Neoplasm and Splanchnic Vein Thrombosis (Mascot)

A Study Assessing Morbidity and Portal Circulation in Patients With Myeloproliferative Neoplasms and Splanchnic Vein Thrombosis

Patients with Myeloproliferative neoplasms are at particular risk for developing arterial and venous thrombosis, especially thrombosis in the splanchnic venous system. The patho-physiology and natural history of MPN related SVT is poorly understood and treatment algorithms vary greatly. This is of considerable importance since the morbidity and mortality in this group of patients is high. This study aims to observe patients with MPN related SVT over a period of five years to document their clinical progress. Methods of observation include clinical assessment, standard investigations and laboratory based research investigations

Study Overview

• Status: Active, not recruiting
• Conditions: Myeloproliferative Disorders; Myeloproliferative Neoplasm; Splanchnic Vein Thrombosis; Splanchnic Venous Thrombosis
• Intervention / Treatment: Other: standard of care.

Detailed 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 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

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

as above

Description

Inclusion Criteria:

1. MPN with SVT between 3 weeks to 5 years of diagnosis of SVT: study arm
2. MPN with palpable splenomegaly or enlarged by Ultrasound: control arm

Exclusion Criteria:

Age <18 years Patients with SVT without MPN

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months	analysed by radiologic investigations and clinical progress	12-18 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Occurrence or changes in morbidity over 5 years 2. Occurrence or changes in portal circulation over 5 years	analysed by radiologic investigations and clinical progress	5 years from baseline

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: University Hospital Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2014
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: anticoagulation; thrombosis; TIPSS; splanchnic; myeloproliferative
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Bone Marrow Diseases; Hematologic Diseases; Embolism and Thrombosis; Neoplasms; Thrombosis; Venous Thrombosis; Myeloproliferative Disorders
• Other Study ID Numbers: MPN-SVT v11; 02/Dec/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No