NCT00631423

Brief Summary

The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in terms of etiology, clinical course and prognosis during long-term follow-up. Patients with isolated lower extremity DVT, matched for age and gender, serve as controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

6.8 years

First QC Date

February 27, 2008

Last Update Submit

April 14, 2015

Conditions

Inferior Vena Cava ThrombosisVenous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Recurrent venous thromboembolism

    6, 12, 24 and 60 months

Secondary Outcomes (2)

  • All-cause mortality

    6, 12, 24 and 60 months

  • Post-thrombotic syndrome

    24 and 60 months

Study Arms (2)

1

Patients with vena cava inferior thrombosis

2

Patients with isolated lower-extremity DVT matched for gender and age

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with venous thrombosis involving the inferior cava inferior obtained from the Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our department are registered

You may qualify if:

  • age 18-90 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt

Frankfurt am Main, Hesse, D-60590, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Birgit Linnemann, MD

    Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt/Main, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

July 1, 2007

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

DE(1)