Clinical trial NCT01444612: Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery
Official title: Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis, Venous
Keywords: cancer surgery
venous thromboembolism
hospitalization
anticoagulants
costs and cost analysis
thromboprophylaxis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-03
Enrollment: 4068
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older with at least one primary inpatient discharge diagnosis of cancer who experienced a cancer-related surgery during the hospitalization were the initial target population.

Brief 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 Database™. 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.


Eligibility 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

Primary outcomes:
measure: Rate of occurence of venous thromboembolism (VTE) during index hospitalization
timeFrame: 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.
measure: Rate of occurence of major bleeding events during hospitalization
timeFrame: 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.
measure: Rate of Hospital readmission rates
timeFrame: Data will be collected over a 5 year and 8 month period with this endpoint evaluated at one month following the date of hospital discharge
measure: Mean length of hospital stay in days
timeFrame: 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.
measure: Total cost of care for index hospitalization in United States (US) dollars
timeFrame: 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.
Secondary outcomes:
measure: Rate of occurence of VTE events during hospitalization plus 1 month post discharge.
timeFrame: Data will be collected over a 5 year and 8 month period with this endpoint evaluated from the date of admission for the index hospitalization to the end of the 1-month post-discharge follow-up period
measure: Rate of occurence of major bleeding events during hospitalization plus 1 month post discharge
timeFrame: Data will be collected over a 5 year and 8 month period with this endpoint evaluated from the date of admission for the index hospitalization to the end of the 1-month post-discharge follow-up period
measure: Total cost of care for index hospitalization plus follow up in US dollars
timeFrame: Data will be collected over a 5 year and 8 month period with this endpoint evaluated from the date of the index hospitalization to the end of the 1-month post-discharge follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: