Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Multi-Center Human Alert Trial to Prevent DVT and PE

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00409136
First received: December 7, 2006
Last updated: January 29, 2009
Last verified: January 2009
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients

Resource links provided by NLM:


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 ]

Enrollment: 2496
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.

  Show Detailed Description

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: December 7, 2006
Last Updated: January 29, 2009
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

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

ClinicalTrials.gov processed this record on November 25, 2014