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

May 15, 2017 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer-related surgery patient records
Healthcare claims records from patients aged 18 years or older with at least one primary inpatient discharge diagnosis of cancer and a cancer-related surgery during the hospitalization
Drug: dalteparin
An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received dalteparin during one day prior to or two days after cancer-related surgery during the hospitalization.
Other Names:
  • Fragmin® is a registered trademark of Pfizer Health AB
Drug: enoxaparin
An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received enoxaparin during one day prior to or two days after cancer-related surgery during the hospitalization.
Other Names:
  • Lovenox® is a registered trademark of Sanofi-Aventis
Drug: fondaparinux
An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received fondaparinux during one day prior to or two days after cancer-related surgery during the hospitalization.
Other Names:
  • Arixtra® is a registered trademark of GlaxoSmithKline
Drug: unfractionated heparin
An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients unfractionated heparin received during one day prior to or two days after cancer-related surgery during the hospitalization.
Other Names:
  • heparin misc
  • heparin Ca
  • Calciparine
  • heparin beef lung
  • heparin Na
  • heparin/Ns
  • heparin/D5%
  • heparin/ns misc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of occurence of venous thromboembolism (VTE) during index hospitalization
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.
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
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
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.
Major bleeding events were identified according to ICD-9 codes for major bleed (568.81, 430.xx, 431.xx, 432.xx, or 998.11) or other bleeding accompanied by more than 2 units of blood transfused (246.3, 286.5, 287.3, 287.4, 287.5, 287.8, 287.9, 459.0, 530.82, 569.3, 578.x, 596.7, 599.7, 719.1, 784.7, 784.8, 786.3, 958.2, or 997.02) as recorded in the billing file during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.
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
Time Frame: 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
Readmission rates were defined as a subsequent hospitalization for major bleeding or VTE that occurred within the follow-up period (discharge month plus 1 month).
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
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.
Length of hospital stay was obtained from the discharge record and was defined as the number of days from patient admission to the hospital for cancer-related surgery until discharge from the hospital.
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
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.
The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from the index hospitalization. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of occurence of VTE events during hospitalization plus 1 month post discharge.
Time Frame: 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
VTE events were identified according to ICD-9 codes for DVT and PE during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.
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
Time Frame: 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
Major bleeding events were identified according to ICD-9 codes for hemoperitoneum bleed, intracranial hemorrhage/hemorrhagic stroke, hemorrhage complicating a procedure, or other bleeding accompanied by more than 2 units of blood transfused as recorded in the billing file during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.
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
Time Frame: 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
The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from both the index hospitalization and the 1-month follow-up period. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

September 29, 2011

First Posted (ESTIMATE)

October 3, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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