High-dose Periop Statins for Prevention of DVT

Not Applicable

Completed

• Conditions: Gynecologic Oncological Pelvic/Abdominal Surgery

• Registration Number: NCT00259662
• Lead Sponsor: Yale University

Brief Summary

This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

• gynecologic tumor scheduled for resection

Exclusion Criteria

• prior reaction to statins
• renal insufficiency
• liver disease
• h/o alcoholism
• prior h/o DVT or hypercoagulability
• concurrent medications that significantly affect cytochrome P450 3A4
• breast feeding or pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease in incidence of deep vein thrombosis

Secondary Outcome Measures

Name	Time	Method
Decrease in inflammatory mediator release.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States