Retrospective Study to Review Patients at Risk for VTE at... | NCT00604370

Studies
Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge

NCT00604370

Sponsor

Brigham and Women's Hospital

Status

Completed

Last Update Posted

Feb 10, 2012Estimated

Enrollment

2,500Actual

Phase

Not provided

Conditions

Venous Thromboembolism

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Feb 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Jan 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2012

Last Update Posted Date

Feb 10, 2012Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.

To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.

We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptomatic PE/DVT within 90 days of hospital discharge.		90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel Z Goldhaber, MD	Brigham and Women's Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054556	Venous Thromboembolism

Ancestor Terms

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided