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Multi-Center Human Alert Trial to Prevent DVT and PE

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ClinicalTrials.gov Identifier: NCT00409136
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : February 2, 2009
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment
Pulmonary Embolism Deep Vein Thrombosis Cancer Surgery Behavioral: Human Alert

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2496 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients
Study Start Date : March 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Clinically diagnosed DVT and/or PE [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 and 90 days ]
  2. Hemorrhagic events [ Time Frame: 30 and 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409136


  Hide Study Locations
Locations
United States, Arizona
AZ Pulmonary Specialists, Ltd
Scottsdale, Arizona, United States, 85258
United States, California
Long Beach VA Hospital
Long Beach, California, United States, 90822
University of California - Irvine
Orange, California, United States, 92868
University of California - Davis
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Washington Hospital Center
Washington DC, District of Columbia, United States, 20010
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Emory-Crawford Long Hospital
Atlanta, Georgia, United States, 30308
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
North Shore Medical Center
Salem, Massachusetts, United States, 01970
United States, Michigan
Henry Ford Hospital K15
Detroit, Michigan, United States, 48202
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
North Shore University Hospital
Great Neck, New York, United States, 11030
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84103
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
United Hospital System
Kenosha, Wisconsin, United States, 53143
Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00409136     History of Changes
Other Study ID Numbers: 2005-P-002527
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

Keywords provided by Brigham and Women's Hospital:
Alert
Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Prophylaxis
Anticoagulation

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases