NCT01444612

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

Name: Clinical Trial NCT01444612
Creator: GlaxoSmithKline
Keywords: Thrombosis, Venous, dalteparin, drug, clinical trial

GlaxoSmithKline·ClinicalTrials.gov·drugCompleted

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Study focus

Disease/Condition: Thrombosis, Venous
Drug/Device/Intervention: dalteparin
Study type: Observational
Intervention type: drug

Sponsor & location

Primary sponsor: GlaxoSmithKline

Timeline & enrollment

Phase: N/A
Start date: Feb 01, 2010
End date: Nov 01, 2010
Enrollment: 4068 participants

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

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.

ICD-10 classifications

Other venous embolism and thrombosisEmbolism and thrombosis of unspecified veinEmbolism and thrombosis of other specified veinsPerianal venous thrombosisArterial embolism and thrombosis

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT01444612
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT01444612 through Pure Global AI's free database. This phase not specified trial is sponsored by GlaxoSmithKline and is currently Completed. The study focuses on Thrombosis, Venous. Target enrollment is 4068 participants.

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