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Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery - Trial NCT01444612

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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NCT01444612
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Trial Details
ClinicalTrials.gov โ€ข NCT01444612
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Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

Study Focus

Thrombosis, Venous

dalteparin

Observational

drug

Sponsor & Location

GlaxoSmithKline

Timeline & Enrollment

N/A

Feb 01, 2010

Nov 01, 2010

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 Databaseโ„ข. 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 thrombosis
Embolism and thrombosis of unspecified vein
Embolism and thrombosis of other specified veins
Perianal venous thrombosis
Arterial embolism and thrombosis

Data Source

ClinicalTrials.gov

NCT01444612

Non-Device Trial