Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery

Sanofi151 enrolled

Overview

The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.

Study Type

INTERVENTIONAL

Purpose

PREVENTION

Masking

NONE

Enrollment

151

Conditions

Abdominal Neoplasms

Interventions

enoxaparinDRUG

20 mg twice a day

Physical prophylaxisOTHER

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more. Exclusion Criteria: * surgery under laparoscope and other endoscopic operations * clinical signs of deep vein thrombosis * use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration * severe hepatic disease or renal disease * women of childbearing potential, pregnant or lactating.

Locations (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Outcomes

Primary Outcomes

Venous thromboembolism incidence

Time frame: 28 days

Secondary Outcomes

Incidence of deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism incidence except patients with thrombus only in muscle veins, and incidence of proximal vein thrombosis

Time frame: 28 days

Data from ClinicalTrials.gov

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