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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01444612
First received: June 23, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Thrombosis, Venous
Drug: dalteparin
Drug: enoxaparin
Drug: fondaparinux
Drug: unfractionated heparin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 4068
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444612

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01444612     History of Changes
Other Study ID Numbers: 113164
Study First Received: June 23, 2011
Last Updated: October 6, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
cancer surgery
venous thromboembolism
hospitalization
anticoagulants
costs and cost analysis
thromboprophylaxis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Fondaparinux
PENTA
Anticoagulants
Heparin
Dalteparin
Heparin, Low-Molecular-Weight
Enoxaparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014