NCT00550082

Brief Summary

Evaluation of physician responses to BICS-Clinical Information 3-screen alerts that informs the clinician that his/her patient may be eligible for thromboprophylaxis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

2.3 years

First QC Date

October 24, 2007

Last Update Submit

February 9, 2012

Conditions

Keywords

AnticoagulationHigh-RiskDeep Vein ThrombosisPulmonary EmbolismSurgery

Outcome Measures

Primary Outcomes (1)

  • Venous Thromboembolism and Bleeding Events

    90 Days

Secondary Outcomes (2)

  • Re-hospitalization

    90 Days

  • Mortality

    30 Days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients at Brigham and Women's Hospital from medical and surgical services who are 18 yrs old or older and are at a moderate to high risk for venous thromboembolism (VTE)

You may qualify if:

  • Hospitalized patients at Brigham and Women's Hospital from medical and surgical services who are 18 yrs old or older and are at a moderate to high risk for venous thromboembolism (VTE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (12)

  • Parasuraman S, Goldhaber SZ. Venous thromboembolism in children. Circulation. 2006 Jan 17;113(2):e12-6. doi: 10.1161/CIRCULATIONAHA.105.583773. No abstract available.

    PMID: 16418440BACKGROUND
  • Piazza G, Goldhaber SZ. Acute pulmonary embolism: part II: treatment and prophylaxis. Circulation. 2006 Jul 18;114(3):e42-7. doi: 10.1161/CIRCULATIONAHA.106.620880. No abstract available.

    PMID: 16847156BACKGROUND
  • Piazza G, Goldhaber SZ. Acute pulmonary embolism: part I: epidemiology and diagnosis. Circulation. 2006 Jul 11;114(2):e28-32. doi: 10.1161/CIRCULATIONAHA.106.620872. No abstract available.

    PMID: 16831989BACKGROUND
  • Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

    PMID: 15383478BACKGROUND
  • Paterno MD, Cina JL, Goldhaber SZ, Kucher N. Preventing DVT and PE in hospitalized patients: improving a successful electronic alert. AMIA Annu Symp Proc. 2006;2006:1058.

    PMID: 17238677BACKGROUND
  • Kucher N, Goldhaber SZ. Risk stratification of acute pulmonary embolism. Semin Thromb Hemost. 2006 Nov;32(8):838-47. doi: 10.1055/s-2006-955466.

    PMID: 17171598BACKGROUND
  • 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. doi: 10.1056/NEJMoa041533.

    PMID: 15758007BACKGROUND
  • 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. doi: 10.1378/chest.118.6.1680.

    PMID: 11115458BACKGROUND
  • Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. doi: 10.1161/01.CIR.0000150393.51958.54. No abstract available.

    PMID: 15630031BACKGROUND
  • 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. doi: 10.1016/j.amjcard.2003.09.057.

    PMID: 14715365BACKGROUND
  • Cushman M, Tsai AW, White RH, Heckbert SR, Rosamond WD, Enright P, Folsom AR. Deep vein thrombosis and pulmonary embolism in two cohorts: the longitudinal investigation of thromboembolism etiology. Am J Med. 2004 Jul 1;117(1):19-25. doi: 10.1016/j.amjmed.2004.01.018.

    PMID: 15210384BACKGROUND
  • Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8.

    PMID: 2025141BACKGROUND

Related Links

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismNeoplasms

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Samuel Z Goldhaber, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, VTE Research Group

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 26, 2007

Study Start

July 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations