NCT04631458

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

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 Nov 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 12, 2014

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

7.1 years

First QC Date

November 10, 2020

Last Update Submit

September 14, 2021

Conditions

Myeloproliferative NeoplasmSplanchnic Vein ThrombosisSplanchnic Venous ThrombosisMyeloproliferative Disorders

Keywords

thrombosissplanchnicanticoagulationTIPSSmyeloproliferative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 1. Occurrence or changes in morbidity over 5 years 2. Occurrence or changes in portal circulation over 5 years

    5 years from baseline

Interventions

standard of care.OTHER

Observational trial.

Eligibility Criteria

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

as above

You may qualify if:

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

You may not qualify if:

  • Age \<18 years Patients with SVT without MPN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myeloproliferative DisordersThrombosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 17, 2020

Study Start

November 12, 2014

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share