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

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ClinicalTrials.gov Identifier: NCT04631458
Recruitment Status : Active, not recruiting
First Posted : November 17, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
University Hospital Birmingham
Information provided by (Responsible Party):
Royal Free Hospital NHS Foundation Trust

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Myeloproliferative Neoplasm Splanchnic Vein Thrombosis Splanchnic Venous Thrombosis Myeloproliferative Disorders 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 Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Study Assessing Morbidity and Portal Circulation in Patients With Myeloproliferative Neoplasms and Splanchnic Vein Thrombosis
Actual Study Start Date : November 12, 2014
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: standard of care.
    Observational trial.

Outcome Measures
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Primary Outcome Measures :
  1. Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months [ Time Frame: 12-18 months from baseline ]
    analysed by radiologic investigations and clinical progress


Secondary Outcome Measures :
  1. 1. Occurrence or changes in morbidity over 5 years 2. Occurrence or changes in portal circulation over 5 years [ Time Frame: 5 years from baseline ]
    analysed by radiologic investigations and clinical progress


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
as above
Criteria

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

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04631458    
Other Study ID Numbers: MPN-SVT v11; 02/Dec/2013
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Free Hospital NHS Foundation Trust:
thrombosis
splanchnic
anticoagulation
TIPSS
myeloproliferative
Additional relevant MeSH terms:
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Neoplasms
Thrombosis
Venous Thrombosis
Myeloproliferative Disorders
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Bone Marrow Diseases
Hematologic Diseases