NCT02113475

Brief Summary

Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

5.9 years

First QC Date

April 9, 2014

Last Update Submit

March 18, 2015

Conditions

Deep Venous ThrombosisPost Thrombotic Syndrome

Keywords

CDTPCDTDVTPTSQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Quality of Life,

    60 months

Secondary Outcomes (1)

  • Rate of Post-Thrombotic Syndrome

    60 Months

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating study centers will enroll patients and enter data in the web-based registry that include demographics, clinical features,

You may qualify if:

  • Data obtained in line with good clinical practice, applicable laws and regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart & Vascular Outcomes Research Institute

Beverly, Massachusetts, 01915, United States

RECRUITING

MeSH Terms

Conditions

Venous ThrombosisPostthrombotic Syndrome

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVenous Insufficiency

Study Officials

  • Uchenna N Onyeachom

    Heart and Vascular Outcomes Research Institute

    STUDY DIRECTOR

Central Study Contacts

Uchenna N Onyeachom

CONTACT

978-927-7800uonyeachom@hvori.org

Study Design

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

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2020

Study Completion

January 1, 2021

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

US(1)