Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
Phase 3
Completed
- Conditions
- Abdominal Neoplasms
- Interventions
- Other: Physical prophylaxis
- Registration Number
- NCT00723216
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 enoxaparin Enoxaparin 2 Physical prophylaxis Intermittent Pneumatic Compression (IPC)
- Primary Outcome Measures
Name Time Method Venous thromboembolism incidence 28 days
- Secondary Outcome Measures
Name Time Method 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 28 days
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇯🇵Tokyo, Japan