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Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery


N/A
18 Years
N/A
Not Enrolling
Both
Thrombosis, Venous

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Trial Information

Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery


Inclusion Criteria:



- age 18 and older

- at least one record of a primary inpatient discharge diagnosis of cancer (index
hospitalization)

- a procedure code for a cancer-related surgery during the index hospitalization

- a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or
unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to
or two days after cancer-related surgery during the index hospitalization (this is
the INDEX EVENT)

Exclusion Criteria:

- a record that the patient received more than one injectable anticoagulant on Day 1 of
anticoagulant therapy

- a record that the patient received anticoagulant therapy prior to index anticoagulant

- a primary diagnosis code of DVT, PE, or major bleed

- evidence of an outpatient emergency department or hospital outpatient clinic visit
that included a diagnosis code for DVT or PE during the 6 months prior to the index
hospitalization

- patient records for patients transferred from another facility outside Premier system
on index hospitalization

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Rate of occurence of venous thromboembolism (VTE) during index hospitalization

Outcome Description:

VTE events were identified by International Classification of Disease-9 (ICD-9) codes for deep vein thrombosis (451.xx. 453.xx) and pulmonary embolism (415.xx) during the index hospitalization. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes

Outcome Time Frame:

Data will be collected over a 5 year and 8 month period with this endpoint evaluated from the date of hospital admission to the date of hospital discharge.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: No Health Authority

Study ID:

113164

NCT ID:

NCT01444612

Start Date:

February 2010

Completion Date:

November 2010

Related Keywords:

  • Thrombosis, Venous
  • cancer surgery
  • venous thromboembolism
  • hospitalization
  • anticoagulants
  • costs and cost analysis
  • thromboprophylaxis
  • Thrombosis
  • Venous Thrombosis

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