NCT00604370

Brief Summary

An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

December 28, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

2 years

First QC Date

December 28, 2007

Last Update Submit

February 9, 2012

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Symptomatic PE/DVT within 90 days of hospital discharge.

    90 days

Study Arms (2)

1

Acutely ill medical and surgical patients who were hospitalized at BWH, and at-risk for VTE, but were not treated with prophylaxis at hospital discharge.

2

Acutely ill medical and surgical patients who were at risk for VTE at time of hospital discharge and prescribed a prophylaxis strategy.

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acutely ill medical and surgical patients who were hospitalized at BWH and who are at risk for DVT.

You may qualify if:

  • Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Samuel Z Goldhaber, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, VTE Research Group

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 30, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

December 1, 2011

Last Updated

February 10, 2012

Record last verified: 2012-02