We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Center Human Alert Trial to Prevent DVT and PE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409136
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : February 2, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
Contacts and Locations

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


  Show 26 Study Locations
Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z. Goldhaber, MD Brigham and Women's Hospital
More Information

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