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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thrombosis, Venous

Intervention: dalteparin (Drug); enoxaparin (Drug); fondaparinux (Drug); unfractionated heparin (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The effectiveness of fondaparinux compared with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery has been evaluated in database studies; however, the effectiveness of injectable anticoagulant medications following cancer-related surgeries in the practice setting has not been as well documented. The objective of this study is to analyze patient records from a national hospital database and compare the outcomes and costs between four types of injectable anticoagulant medications that were prescribed for the prevention of VTE following cancer-related surgery. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy). The source of data for this study is the Premier Perspective Databaseā„¢. This hospital claims database links de-identified inpatient medical, pharmacy, and billing data from more than 500 hospitals. This study is a retrospective cohort study that uses propensity score matching to adjust for the differences between the numbers of patients treated with each medication.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome:

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

Rate of occurence of major bleeding events during hospitalization

Rate of Hospital readmission rates

Mean length of hospital stay in days

Total cost of care for index hospitalization in United States (US) dollars

Secondary outcome:

Rate of occurence of VTE events during hospitalization plus 1 month post discharge.

Rate of occurence of major bleeding events during hospitalization plus 1 month post discharge

Total cost of care for index hospitalization plus follow up in US dollars

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: October 6, 2011

Page last updated: August 23, 2015

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