Last updated: 11/03/2018 14:24:43

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

GSK study ID
113164
See study documents
Clinicaltrials.gov ID
NCT01444612
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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.

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.

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

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.

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:

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

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

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

Interventions:
  • Drug: dalteparin
  • Drug: enoxaparin
  • Drug: fondaparinux
  • Drug: unfractionated heparin
    • Enrollment:
    4068
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Thrombosis, Venous
    Product
    fondaparinux sodium
    Collaborators
    Not applicable
    Study date(s)
    February 2010 to October 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • age 18 and older
    • at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization)
    • 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
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-01-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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