Multi-Center Human Alert Trial to Prevent DVT and PE - Full Text View

Purpose

To evaluate physician response to human alerts that inform the clinician that his/her patient may be eligible for thromboprophylaxis. Medical records are reviewed to evaluate prescribing decision and to evaluate rates of venous thromboembolism.

Condition	Intervention
Pulmonary Embolism Deep Vein Thrombosis Cancer Surgery	Behavioral: Human Alert

MedlinePlus related topics:

Deep Vein Thrombosis Pulmonary Embolism

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Clinically diagnosed DVT and/or PE [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
Hemorrhagic events [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2500
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2008

Groups/Cohorts	Assigned Interventions
Alert Physicians alerted about their high risk patients who are not receiving any VTE prophylaxis.	Behavioral: Human Alert An alert from study staff informing a physician that his/her patient is at high risk for DVT and/or PE, but is not receiving any prophylaxis.
No Alert Physicians not alerted about their high risk patients who are not receiving any VTE prophylaxis.	Behavioral: Human Alert An alert from study staff informing a physician that his/her patient is at high risk for DVT and/or PE, but is not receiving any prophylaxis.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Hospitalized patients that have a cumulative VTE risk score of 4 or more with no orders for prophylactic measures.

Criteria

Inclusion Criteria:

Patients > 18 years of age
Cumulative VTE risk score > 4
Absence of pharmacologic or mechanical prophylaxis orders
Patients from medical or surgical Services

Exclusion Criteria:

VTE risk score <4
Current active pharmacologic or mechanical prophylaxis order
Patients from the Department of Neurology, Newborn Service, Rehab Units, and Neonatal Intensive Care Unit (NICU).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409136

Show 26 Study Locations

Sponsors and Collaborators

Brigham and Women's Hospital

Sanofi-Aventis

Investigators


Principal Investigator:	Samuel Z. Goldhaber, MD	Brigham and Women's Hospital

More Information

North American Thrombosis Forum This link exits the ClinicalTrials.gov site

Publications:

Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. Review. No abstract available.

Goldhaber SZ, Dunn K, MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women's Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest. 2000 Dec;118(6):1680-4.

Goldhaber SZ, Tapson VF; DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol. 2004 Jan 15;93(2):259-62.

Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77.

Responsible Party:	Brigham and Women's Hospital ( Samuel Z. Goldhaber, MD )
Study ID Numbers:	2005-P-002527
First Received:	December 7, 2006
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00409136
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Alert

Deep Vein Thrombosis

Pulmonary Embolism

Venous Thromboembolism

Prophylaxis

Anticoagulation

Study placed in the following topic categories:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vascular Diseases

Venous Thrombosis

Venous Thromboembolism

Thromboembolism

Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Brigham and Women's Hospital Sanofi-Aventis
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00409136