High-dose Periop Statins for Prevention of DVT

Yale University29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Gynecologic Oncological Pelvic/Abdominal Surgery

Interventions

atorvastatinDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale-New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Decrease in incidence of deep vein thrombosis

Secondary Outcomes

Decrease in inflammatory mediator release.

Data from ClinicalTrials.gov

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